K842256 is an FDA 510(k) clearance for the AS LATEX PLUS. This device is classified as a Antistreptolysin - Titer/streptolysin O Reagent (Class I - General Controls, product code GTQ).
Submitted by Biokit USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984, 12 days after receiving the submission on June 7, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K842256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1984 |
| Decision Date | June 19, 1984 |
| Days to Decision | 12 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 |