FDA 510(k) Applications Submitted by DAVID L CALLENDER

FDA 510(k) Number Submission Date Device Name Applicant
K860142 01/14/1986 URIC ACID REAGENT SET (COLORIMETRIC) STERLING DIAGNOSTICS, INC.
K860475 02/07/1986 HEMOGLOBIN REAGENT SET STERLING DIAGNOSTICS, INC.
K860476 02/07/1986 ACID PHOSPHATASE REAGENT SET STERLING DIAGNOSTICS, INC.
K860477 02/07/1986 URIC ACID REAGNET SET (TRINDER) STERLING DIAGNOSTICS, INC.
K860478 02/07/1986 SERUM IRON & IRON BINDING REAGENT SET STERLING DIAGNOSTICS, INC.
K860628 02/19/1986 INORGANIC PHOSPHORUS REAGENT SET STERLING DIAGNOSTICS, INC.
K861713 05/05/1986 SERUM POTASSIUM REAGENT SET STERLING DIAGNOSTICS, INC.
K933722 08/02/1993 HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT HORIZON DIAGNOSTICS, INC.
K935712 11/30/1993 IRON/TIBC REAGENT HORIZON DIAGNOSTICS, INC.
K855164 12/26/1985 ENZYNATIC TRIGLYCERIDES REAGENT SET STERLING DIAGNOSTICS, INC.
K860044 01/06/1986 CALCIUM (CPC) REAGENT SET STERLING DIAGNOSTICS, INC.
K860096 01/10/1986 CPK REAGENT SET (COLORIMETRIC) STERLING DIAGNOSTICS, INC.
K860154 01/16/1986 BUN (ENZYMATIC BERTHELOT) REAGENT SET STERLING DIAGNOSTICS, INC.
K860214 01/22/1986 TOTAL BILIRUBIN REAGENT SET STERLING DIAGNOSTICS, INC.
K860215 01/22/1986 MAGNESIUM REAGENT SET STERLING DIAGNOSTICS, INC.
K860216 01/22/1986 SGOT (AST) REAGENT SET STERLING DIAGNOSTICS, INC.
K860340 01/29/1986 SERUM ALBUMIN (BCG) REAGENT SET STERLING DIAGNOSTICS, INC.
K860341 01/29/1986 TOTAL PROTEIN (BIURET) REAGENT SET STERLING DIAGNOSTICS, INC.
K860348 01/30/1986 GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET STERLING DIAGNOSTICS, INC.
K860349 01/30/1986 LACTATE DEHYDROGENASE (LDH) REAGENT SET STERLING DIAGNOSTICS, INC.
K860350 01/30/1986 SERUM CHOLINESTERASE REAGENT SET STERLING DIAGNOSTICS, INC.
K860351 01/30/1986 ALKALINE PHOSPHATASE REAGENT SET STERLING DIAGNOSTICS, INC.
K860418 02/04/1986 CREATININE REAGENT SET STERLING DIAGNOSTICS, INC.
K860419 02/04/1986 UREA NITROGEN REAGENT SET STERLING DIAGNOSTICS, INC.
K860420 02/04/1986 SICKLE CELL REAGENT SET STERLING DIAGNOSTICS, INC.
K860485 02/10/1986 SGPT (ALT) REAGENT SET (COLORIMETRIC) STERLING DIAGNOSTICS, INC.
K860530 02/12/1986 AMYLASE REAGENT SET (MODIFIED CARAWAY) STERLING DIAGNOSTICS, INC.
K860554 02/14/1986 SERUM LIPASE REAGENT SET (TURBIDIMETRIC) STERLING DIAGNOSTICS, INC.
K860667 02/24/1986 ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET STERLING DIAGNOSTICS, INC.
K921412 03/24/1992 MICROPROTEIN REAGENT SET STERLING DIAGNOSTICS, INC.
K861311 04/08/1986 GLUCOSE (HEXOKINASE) REAGENT SET STERLING DIAGNOSTICS, INC.
K861615 04/29/1986 SALICYLATE REAGENT SET STERLING DIAGNOSTICS, INC.
K971566 04/29/1997 CREATINE KINASE-MB REAGENT SET HORIZON DIAGNOSTICS, INC.
K861855 05/14/1986 HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET STERLING DIAGNOSTICS, INC.
K861962 05/20/1986 VANILMANDELIC ACID (VMA) REAGENT SET STERLING DIAGNOSTICS, INC.
K862209 06/10/1986 ALT (SGPT) REAGENT SET (UV RATE) STERLING DIAGNOSTICS, INC.
K862210 06/10/1986 UREA NITROGEN (GLDH) REAGENT SET (UV) STERLING DIAGNOSTICS, INC.
K862255 06/13/1986 LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) STERLING DIAGNOSTICS, INC.
K862256 06/13/1986 ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET STERLING DIAGNOSTICS, INC.
K914039 09/10/1991 SODIUM REAGENT SET STERLING DIAGNOSTICS, INC.
K914040 09/10/1991 PHOSPHOLIPID REAGENT SET STERLING DIAGNOSTICS, INC.
K914609 10/17/1991 TRIGLYCERIDES REAGENT SET STERLING DIAGNOSTICS, INC.
K854335 10/28/1985 GLUCOSE REAGENT SET (GOD/TRINDER) STERLING DIAGNOSTICS, INC.
K844251 11/02/1984 ALT/GPT REAGENT SET STERLING BIOCHEMICAL, INC.
K855028 12/16/1985 TOTAL CHOLESTEROL REAGENT SET STERLING DIAGNOSTICS, INC.
K844998 12/26/1984 GLUCOSE(HEXOKINASE) REAGENT SET STERLING BIOCHEMICAL, INC.


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