K946373 is an FDA 510(k) clearance for the MYCOPLASMA SLURRY AND MYCOPLASMA CROWNTITRE IFA TEST SYSTEM. This device is classified as a Antisera, Fluorescent, All, Mycoplasma Spp. (Class I - General Controls, product code GRZ).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on February 7, 1996, 518 days after receiving the submission on September 7, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3375.
| 510(k) Number | K946373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1994 |
| Decision Date | February 07, 1996 |
| Days to Decision | 518 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GRZ — Antisera, Fluorescent, All, Mycoplasma Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3375 |