K904311 is an FDA 510(k) clearance for the RHEUMAGEN ASO T-CONTROL. This device is classified as a Antistreptolysin - Titer/streptolysin O Reagent (Class I - General Controls, product code GTQ).
Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on January 25, 1991, 128 days after receiving the submission on September 19, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K904311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1990 |
| Decision Date | January 25, 1991 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTQ — Antistreptolysin - Titer/streptolysin O Reagent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3720 |