K853276 is an FDA 510(k) clearance for the ASO SLIDE EIKEN. This device is classified as a Antistreptolysin - Titer/streptolysin O Reagent (Class I - General Controls, product code GTQ).
Submitted by Syn-Kit, Inc. (Chatsworth, US). The FDA issued a Cleared decision on August 20, 1985, 15 days after receiving the submission on August 5, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3720.
| 510(k) Number | K853276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1985 |
| Decision Date | August 20, 1985 |
| Days to Decision | 15 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 |