K842839 is an FDA 510(k) clearance for the SERIMM SURE ASO-CHEK CONTROL SERUM. This device is classified as a Antistreptolysin - Titer/streptolysin O Reagent (Class I - General Controls, product code GTQ).
Submitted by Analytical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 23, 1984, 34 days after receiving the submission on July 20, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K842839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1984 |
| Decision Date | August 23, 1984 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GTQ — Antistreptolysin - Titer/streptolysin O Reagent |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3720 |