FDA 510(k) Applications for Medical Device Product Code "DGR"
(Whole Human Serum, Antigen, Antiserum, Control)

FDA 510(k) Number Applicant Device Name Decision Date
K781355 BECKMAN INSTRUMENTS, INC. ICS NORMAL CONTROL SERUM 08/31/1978
K865014 BIO-RAD LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II 01/09/1987
K902220 BOEHRINGER MANNHEIM CORP. PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL 09/05/1990
K961544 CONSOLIDATED TECHNOLOGIES, INC. QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 09/24/1996
K790298 KALLESTAD LABORATORIES, INC. RADIOASSAY, CONTROL SERUM I, II, III 04/04/1979


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