K895461 is an FDA 510(k) clearance for the WELLCOLEX COLOUR SHIGELLA TEST ZC51. This device is classified as a Antisera, All Types, Shigella Spp. (Class II - Special Controls, product code GNB).
Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on January 11, 1990, 127 days after receiving the submission on September 6, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3660.
| 510(k) Number | K895461 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1989 |
| Decision Date | January 11, 1990 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GNB — Antisera, All Types, Shigella Spp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3660 |