Panels › Microbiology › Product code LSK · Class 1
Dna-Reagents, Chlamydia
Regulation 866.3120
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LSK
| Company | 510(k)s | Recalls |
|---|---|---|
| Gen-Probe, Inc. | 4 | 0 |
| Digene Corp. | 3 | 0 |
| Abbott Molecular, Inc. | 1 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 28, 2010 | K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 Abbott Molecular, Inc. | LSK |
| Sep 25, 2001 | K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 Digene Corp. | LSK |
| Sep 24, 2001 | K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 Digene Corp. | LSK |
| Oct 25, 1999 | K990023 | HYBRID CAPTURE II CT-ID TEST Digene Corp. | LSK |
| Apr 6, 1994 | K920302 | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY Gen-Probe, Inc. | LSK |
| Apr 29, 1992 | K920378 | PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS Gen-Probe, Inc. | LSK |
| Dec 29, 1987 | K874878 | GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS Gen-Probe, Inc. | LSK |
| Oct 28, 1987 | K871878 | RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS Gen-Probe, Inc. | LSK |
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