LSK — Dna-Reagents, Chlamydia Class I
FDA Device Classification
Classification Details
- Product Code
- LSK
- Device Class
- Class I
- Regulation Number
- 866.3120
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K092704 | abbott molecular | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8 | May 28, 2010 |
| K010891 | digene | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | September 25, 2001 |
| K010892 | digene | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-01 | September 24, 2001 |
| K990023 | digene | HYBRID CAPTURE II CT-ID TEST | October 25, 1999 |
| K920302 | gen-probe | PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY | April 6, 1994 |
| K920378 | gen-probe | PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS | April 29, 1992 |
| K874878 | gen-probe | GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS | December 29, 1987 |
| K871878 | gen-probe | RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS | October 28, 1987 |