Panels › Microbiology › Product code LKI · Class 1
Antisera, Fluorescent, Chlamydia Spp.
Regulation 866.3120
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LKI
| Company | 510(k)s | Recalls |
|---|---|---|
| Bion Ent., Ltd. | 1 | 0 |
| Btc Corp. | 1 | 0 |
| Immco Diagnostics, Inc. | 1 | 0 |
| Immulok, Inc. | 1 | 0 |
| Serono Diagnostics, Inc. | 1 | 0 |
| Stellar Bio Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 1992 | K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY Stellar Bio Systems, Inc. | LKI |
| Jan 25, 1991 | K905531 | LUPUS(LE)-LATEX TEST Immco Diagnostics, Inc. | LKI |
| Aug 15, 1989 | K894625 | CHLAMYDIA (LGV-1) Bion Ent., Ltd. | LKI |
| Feb 3, 1989 | K883776 | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE Btc Corp. | LKI |
| Jan 28, 1986 | K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES Serono Diagnostics, Inc. | LKI |
| May 4, 1983 | K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND Immulok, Inc. | LKI |
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