K854991 is an FDA 510(k) clearance for the REUMAGEN ASL. 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 April 18, 1986, 127 days after receiving the submission on December 12, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K854991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1985 |
| Decision Date | April 18, 1986 |
| Days to Decision | 127 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 |