LQO — Dna-Reagents, Campylobacter Spp. Class I
FDA product code LQO covers "Dna-Reagents, Campylobacter Spp.", a Class I medical device regulated under 21 CFR 866.3110. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LQO
- Device Class
- Class I
- Regulation Number
- 866.3110
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K894712 | gen-probe | ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATION | November 14, 1989 |
| K873670 | molecular biosystems | SNAP CAMPYLOBACTOR DIAGNOSTIC KIT | June 8, 1988 |
| K875101 | wampole laboratories | VIROGEN CMV ANTIBODY TEST | March 1, 1988 |
| K863270 | integrated genetics | GENE-TRAK CAMPYLOBACTER ASSAY | August 31, 1987 |