K863270 is an FDA 510(k) clearance for the GENE-TRAK CAMPYLOBACTER ASSAY. This device is classified as a Dna-reagents, Campylobacter Spp. (Class I - General Controls, product code LQO).
Submitted by Integrated Genetics (Framingham, US). The FDA issued a Cleared decision on August 31, 1987, 371 days after receiving the submission on August 25, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K863270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1986 |
| Decision Date | August 31, 1987 |
| Days to Decision | 371 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LQO — Dna-reagents, Campylobacter Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |