FDA 510(k) Applications for Medical Device Product Code "CEX"
(Chromatographic Separation, Lactate Dehydrogenase Isoenzymes)

FDA 510(k) Number Applicant Device Name Decision Date
K842018 BERWICK MEDICAL PRODUCTS, INC. ISO-SEP SYSTEM 09/28/1984
K771894 BIO-REAGENTS & DIAGNOSTICS, INC. LDH ISOENZYME CONTROL 12/22/1977
K872891 DATA MEDICAL ASSOCIATES, INC. LACTATE DEHYDROGENASE ISOENZYME 1 09/16/1987
K821879 HARLECO DIAGNOSTICS ULTRACHEM T.P. 07/14/1982
K821983 HELENA LABORATORIES TITAN GEL LDH ISOENZYME KIT 12/22/1982
K851521 SERAGEN DIAGNOSTICS, INC. LD-1(IMMUNO) SEPARATION SET 05/10/1985
K800129 UNION CARBIDE CORP. CENTRIFICHEM CREATININE 02/13/1980
K772356 WORTHINGTON BIOCHEMICAL CORP. LDH ISOENZYME COLUMN REAGENT SET 01/24/1978


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