FDA 510(k) Applications for Medical Device Product Code "DJB"
(Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.)

FDA 510(k) Number Applicant Device Name Decision Date
K782049 ABBOTT LABORATORIES BIOASSAY SYSTEM, MS-2 SERUM 08/28/1979
K800537 ALPHA GAMMA LABORATORY GAMMA STICK GENTAMICIN RIA KIT 04/24/1980
K780516 ANTIBODIES INC. GENTAMICIN RIA KIT 04/28/1978
K781674 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC MACRO-VUE TEST, GENTAMICIN 11/15/1978
K791547 BIO-RAD FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY 10/12/1979
K791770 BIO-RAD QUANTIMUNE GENTAMICIN RIA GENTAMICIN 10/17/1979
K761157 DIAGNOSTIC PRODUCTS CORP. AMINOGLYCOSIDE (125I) RIA KIT 03/01/1977
K811844 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT GENTAMICIN RIA KIT 07/10/1981
K782126 DIAGNOSTIC PRODUCTS CORP. RIA KIT, SISOMICIN 02/15/1979
K831210 E.I. DUPONT DE NEMOURS & CO., INC. GENTAMICIN TEST PACK-ACA 05/25/1983
K780323 KALLESTAD LABORATORIES, INC. QUANTITOPE 125-I GENTAMICIN RIA KIT 03/17/1978
K812394 MICROANALYTIC RESEARCH, INC. MRI GENTAMICIN RIA KIT 09/08/1981
K821669 MILES LABORATORIES, INC. AMES TDA GENTAMICIN TEST 12/15/1982
K790584 MILES LABORATORIES, INC. AMES TDA/GENTGMICIN 06/15/1979
K760068 NEW ENGLAND NUCLEAR KIT, RIA, GENTAMICIN SULF. 07/20/1976
K772425 NEW ENGLAND NUCLEAR RIANEN GENTAMICIN RIA KIT 01/05/1978
K772116 NICHOLS INSTITUTE DIAGNOSTICS AMINOGLYCOSIDE TEST SYSTEM 04/28/1978
K790829 SYVA CO. EMIT GENTAMICIN ASSAY 05/15/1979


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