Submission Details
| 510(k) Number | K973069 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 1997 |
| Decision Date | September 22, 1997 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON SYSTEMS METHADONE REAGENT
Sep 1997
Decision
35d
Days
Class 2
Risk
About This 510(k) Submission
K973069 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS METHADONE REAGENT, a Enzyme Immunoassay, Methadone (Class II — Special Controls, product code DJR), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on September 22, 1997, 35 days after receiving the submission on August 18, 1997. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3620.
Device Classification
| Product Code | DJR — Enzyme Immunoassay, Methadone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3620 |
Manufacturer
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