K903194 is an FDA 510(k) clearance for the REDITEST STREP A TEST KIT. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 22, 1990, 34 days after receiving the submission on July 19, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K903194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1990 |
| Decision Date | August 22, 1990 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTZ — Antisera, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |