Submission Details
| 510(k) Number | K926236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 1992 |
| Decision Date | June 15, 1993 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BECKMAN ANTI-STREPTOLYSIN O KIT
Jun 1993
Decision
186d
Days
Class 1
Risk
About This 510(k) Submission
K926236 is an FDA 510(k) clearance for the BECKMAN ANTI-STREPTOLYSIN O KIT, a Antistreptolysin - Titer/streptolysin O Reagent (Class I — General Controls, product code GTQ), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 15, 1993, 186 days after receiving the submission on December 11, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3720.
Device Classification
| Product Code | GTQ — Antistreptolysin - Titer/streptolysin O Reagent |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3720 |
Manufacturer
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