K890146 is an FDA 510(k) clearance for the WELLCOLEX COLOUR SALMONELLA TEST ZL 50. This device is classified as a Antisera, All Groups, Salmonella Spp. (Class II - Special Controls, product code GRM).
Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on February 16, 1989, 34 days after receiving the submission on January 13, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3550.
| 510(k) Number | K890146 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 1989 |
| Decision Date | February 16, 1989 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GRM — Antisera, All Groups, Salmonella Spp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3550 |