K913618 is an FDA 510(k) clearance for the ARBOVIRUS IGM IFA TEST. This device is classified as a Antisera, Cf, Equine Encephalitis Virus, Eee, Wee (Class I - General Controls, product code GQC).
Submitted by Hillcrest Biologicals (Cypress, US). The FDA issued a Cleared decision on December 3, 1992, 478 days after receiving the submission on August 13, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3240.
| 510(k) Number | K913618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1991 |
| Decision Date | December 03, 1992 |
| Days to Decision | 478 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQC — Antisera, Cf, Equine Encephalitis Virus, Eee, Wee |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3240 |