LQF — Dna-Reagents, Mycobacterium Spp. Class I
FDA product code LQF covers "Dna-Reagents, Mycobacterium Spp.", a Class I medical device regulated under 21 CFR 866.3370. Submissions are reviewed by the Microbiology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LQF
- Device Class
- Class I
- Regulation Number
- 866.3370
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K921435 | gen-probe | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | July 23, 1992 |
| K904463 | gen-probe | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST | November 13, 1990 |
| K896494 | gen-probe | ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST | August 23, 1990 |
| K897077 | gen-probe | ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE | August 23, 1990 |
| K897078 | gen-probe | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | May 2, 1990 |
| K896492 | gen-probe | ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST | April 16, 1990 |
| K896493 | gen-probe | ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST | April 11, 1990 |
| K900202 | syngene | SNAP MYCOBACTERIA AVIUM COMPLEX | April 3, 1990 |
| K900292 | syngene | SNAP M. TUBERCULOSIS COMPLEX | April 3, 1990 |
| K890089 | gen-probe | RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE | March 13, 1989 |
| K871795 | gen-probe | RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. | July 30, 1987 |
| K864597 | gen-probe | GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA | April 20, 1987 |
| K862613 | gen-probe | RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX | November 10, 1986 |
| K862614 | gen-probe | RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX | November 10, 1986 |
| K860782 | gen-probe | GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM | July 2, 1986 |