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FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K802396 GENERAL PROCEDURE AGAROSE FILMJJN1980-11-26 View
510(k) K792548 ALKALINE PHOSPHATASE MARKERCIN1980-01-29 View
510(k) K792547 AGAROSE BARBITAL BUFFERJJN1980-01-29 View
510(k) K792551 ALKALINE PHOSPHATASE REAGENTCJH1980-01-29 View
510(k) K792553 AGAROSE BARBITAL-EDTA BUFFERJJN1980-01-29 View
510(k) K792574 MOPSO BUFFERJCC1980-01-21 View
510(k) K792550 PONCEAU S STAIN SETKQC1980-01-16 View
510(k) K792552 AMIDO BLACK 10B STAINHZZ1979-12-18 View
510(k) K792549 FAT RED 7B STAIN SETHYD1979-12-18 View
510(k) K791657 LDH ISOENZYME REAGENTCFE1979-09-17 View
510(k) K791655 CPK ISOENZYME REAGENTJHY1979-09-17 View
510(k) K791656 ENZYME STABILIZING REAGENT (ESR)CFE1979-09-17 View
510(k) K791654 NORMAL CONTROLJJY1979-09-17 View
510(k) K791300 LDH ISOENZYME CONTROLJJT1979-08-16 View
510(k) K791299 CPK ISOENZYME CONTROLJJT1979-08-16 View
510(k) K791008 ECA (SPECIAL) HEME BUFFERJBD1979-08-03 View
510(k) K781898 CLEARING SOLUTION #ECA01976JQK1978-12-20 View
510(k) K781122 LIPOPROTEIN STAINHZG1978-08-31 View
510(k) K781121 HEMOLYSEGGK1978-08-14 View
510(k) K781119 ECA HEME BUFFERJBD1978-08-14 View
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