K885004 is an FDA 510(k) clearance for the BACTIGEN(R) N. MENINGITIDIS. This device is classified as a Antisera, All Groups, N. Meningitidis (Class II - Special Controls, product code GTJ).
Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 7, 1989, 68 days after receiving the submission on December 1, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K885004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1988 |
| Decision Date | February 07, 1989 |
| Days to Decision | 68 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 |