Submission Details
| 510(k) Number | K955676 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 1995 |
| Decision Date | March 04, 1996 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON SYSTEMS METHAQUALONE REAGENT
Mar 1996
Decision
80d
Days
Class 2
Risk
About This 510(k) Submission
K955676 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS METHAQUALONE REAGENT, a Radioimmunoassay, Methaqualone (Class II — Special Controls, product code KXS), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 4, 1996, 80 days after receiving the submission on December 15, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3630.
Device Classification
| Product Code | KXS — Radioimmunoassay, Methaqualone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3630 |
Manufacturer
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