FDA 510(k) Applications for Medical Device Product Code "LKH"
(Antisera, Immunoperoxidase, Chlamydia Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K842151 BARTELS IMMUNODIAGNOSTIC SUPPLIES, INC. CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT 07/20/1984
K893669 DIFCO LABORATORIES, INC. CELLMATICS SHLAMYDIA DETECTION SYSTEM 06/23/1989
K882674 ICN IMMUNOBIOLOGICALS IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT 08/15/1989
K820390 IMMULOK, INC. HISTOSET IMMUNOPEROXIDASE TISSURE KIT 04/14/1982
K830688 NICHOLAS H. MAGANIAS COMBION SKIN TEST 03/31/1983
K910644 SAVYON DIAGNOSTICS, LTD. IPAZYME (TM) CHLAMYDIA IGG-IGA 03/19/1991
K901975 SAVYON DIAGNOSTICS, LTD. IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) 03/08/1991
K852869 SCOTT LABORATORIES, INC. SELECTICULT-CHLAMYDIA 09/19/1985


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