FDA 510(k) Applications for Medical Device Product Code "CKD"
(Hydrazone Colorimetry, Alt/Sgpt)

FDA 510(k) Number Applicant Device Name Decision Date
K820491 ANCO MEDICAL REAGENTS & ASSOC. SGPT REAGENT SET 03/11/1982
K864082 BOEHRINGER MANNHEIM CORP. REFLOTRON(R) ALT (GPT) 12/04/1986
K991834 CHOLESTECH CORP. CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 09/09/1999
K884784 ELECTRO-NUCLEONICS, INC. VIRGO(R) MICROWELL ALT ASSAY 12/29/1988
K844283 LIVONIA DIAGNOSTICS, INC. SGPT REAGENT SET 11/27/1984
K841059 MEDICAL SPECIALTIES, INC. SGPT REAGENT SET 05/01/1984
K821207 OMEGA MEDICAL ELECTRONICS SGPT REAGENT SET 07/14/1982
K941192 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO ALT MICROWELL TEST SYSTEM 05/16/1995
K896237 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS READY ALT REAGENT 02/16/1990
K860485 STERLING DIAGNOSTICS, INC. SGPT (ALT) REAGENT SET (COLORIMETRIC) 04/03/1986
K883387 TECH-CO, INC. ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) 10/13/1988


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