LKH · Class I · 21 CFR 866.3120

FDA Product Code LKH: Antisera, Immunoperoxidase, Chlamydia Spp.

Leading manufacturers include Savyon Diagnostics , Ltd., Nicholas H. Maganias and Bartels Immunodiagnostic Supplies, Inc..

8
Total
8
Cleared
126d
Avg days
1982
Since

FDA 510(k) Cleared Antisera, Immunoperoxidase, Chlamydia Spp. Devices (Product Code LKH)

8 devices
1–8 of 8
Cleared Mar 19, 1991
IPAZYME (TM) CHLAMYDIA IGG-IGA
K910644
Savyon Diagnostics , Ltd.
Microbiology · 33d
Cleared Mar 08, 1991
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
K901975
Savyon Diagnostics , Ltd.
Microbiology · 311d
Cleared Aug 15, 1989
IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
K882674
Icn Immunobiologicals
Microbiology · 413d
Cleared Jun 23, 1989
CELLMATICS SHLAMYDIA DETECTION SYSTEM
K893669
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Sep 19, 1985
SELECTICULT-CHLAMYDIA
K852869
Scott Laboratories, Inc.
Microbiology · 73d
Cleared Jul 20, 1984
CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT
K842151
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 51d
Cleared Mar 31, 1983
COMBION SKIN TEST
K830688
Nicholas H. Maganias
Immunology · 27d
Cleared Apr 14, 1982
HISTOSET IMMUNOPEROXIDASE TISSURE KIT
K820390
Immulok, Inc.
Chemistry · 63d

About Product Code LKH - Regulatory Context