LSK
8 FDA 510(k) clearances · Product code
183 daysmedian time to decision
806 days90th percentile
8clearances measured
FDA profile
- Official device name
- Dna-Reagents, Chlamydia
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3120
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1 · 2002: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 (K092704) | Abbott Molecular, Inc. | 2010-05-28 |
| MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 (K010891) | Digene Corp. | 2001-09-25 |
| MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 (K010892) | Digene Corp. | 2001-09-24 |
| HYBRID CAPTURE II CT-ID TEST (K990023) | Digene Corp. | 1999-10-25 |
| PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY (K920302) | Gen-Probe, Inc. | 1994-04-06 |
| PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS (K920378) | Gen-Probe, Inc. | 1992-04-29 |
| GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS (K874878) | Gen-Probe, Inc. | 1987-12-29 |
| RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS (K871878) | Gen-Probe, Inc. | 1987-10-28 |
Track LSK automatically
Every clearance here is in the API, with alerts when new ones post.