Submission Details
| 510(k) Number | K915053 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 1991 |
| Decision Date | March 19, 1992 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
BECKMAN ANTISTREPTOLYSIN O, MODIFICATION
Mar 1992
Decision
140d
Days
Class 1
Risk
About This 510(k) Submission
K915053 is an FDA 510(k) clearance for the BECKMAN ANTISTREPTOLYSIN O, MODIFICATION, 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 March 19, 1992, 140 days after receiving the submission on October 31, 1991. 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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