K884965 is an FDA 510(k) clearance for the BACTIGEN(R) MENINGITIDIS PANEL. This device is classified as a Antisera, All Types, Streptococcus Pneumoniae (Class I - General Controls, product code GWC).
Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 7, 1989, 69 days after receiving the submission on November 30, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K884965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 1988 |
| Decision Date | February 07, 1989 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GWC — Antisera, All Types, Streptococcus Pneumoniae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |