K851949 is an FDA 510(k) clearance for the STAPHAUREX ZL30. This device is classified as a Antisera, Fluorescent, All Types, Staphylococcus Spp. (Class I - General Controls, product code GTN).
Submitted by Wellcome Diagnostics (Research Triangle Pk, US). The FDA issued a Cleared decision on May 22, 1985, 19 days after receiving the submission on May 3, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3700.
| 510(k) Number | K851949 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1985 |
| Decision Date | May 22, 1985 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTN — Antisera, Fluorescent, All Types, Staphylococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3700 |