K851691 is an FDA 510(k) clearance for the WILLCOGEN MENINGITIDIS KIT ZL25. This device is classified as a Antisera, All Groups, N. Meningitidis (Class II - Special Controls, product code GTJ).
Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on June 10, 1985, 48 days after receiving the submission on April 23, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K851691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 1985 |
| Decision Date | June 10, 1985 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTJ — Antisera, All Groups, N. Meningitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |