Panels › Microbiology › Product code LKH · Class 1
Antisera, Immunoperoxidase, Chlamydia Spp.
Regulation 866.3120
0510(k)s in 12 months (8 all time)
0recalls in 12 months (6 all time)
0recalls that name a 510(k)
Top companies in LKH
| Company | 510(k)s | Recalls |
|---|---|---|
| Encore Medical, Lp | 0 | 6 |
| Savyon Diagnostics , Ltd. | 2 | 0 |
| Bartels Immunodiagnostic Supplies, Inc. | 1 | 0 |
| Difco Laboratories, Inc. | 1 | 0 |
| Icn Immunobiologicals | 1 | 0 |
| Immulok, Inc. | 1 | 0 |
| Nicholas H. Maganias | 1 | 0 |
| Scott Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 1991 | K910644 | IPAZYME (TM) CHLAMYDIA IGG-IGA Savyon Diagnostics , Ltd., IL | LKH |
| Mar 8, 1991 | K901975 | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) Savyon Diagnostics , Ltd., IL | LKH |
| Aug 15, 1989 | K882674 | IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT Icn Immunobiologicals | LKH |
| Jun 23, 1989 | K893669 | CELLMATICS SHLAMYDIA DETECTION SYSTEM Difco Laboratories, Inc. | LKH |
| Sep 19, 1985 | K852869 | SELECTICULT-CHLAMYDIA Scott Laboratories, Inc. | LKH |
| Jul 20, 1984 | K842151 | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT Bartels Immunodiagnostic Supplies, Inc. | LKH |
| Mar 31, 1983 | K830688 | COMBION SKIN TEST Nicholas H. Maganias | LKH |
| Apr 14, 1982 | K820390 | HISTOSET IMMUNOPEROXIDASE TISSURE KIT Immulok, Inc. | LKH |
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