Submission Details
| 510(k) Number | K971283 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 07, 1997 |
| Decision Date | June 03, 1997 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON SYSTEMS CAL 5 PLUS
Jun 1997
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K971283 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CAL 5 PLUS, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on June 3, 1997, 57 days after receiving the submission on April 7, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIX — Calibrator, Multi-analyte Mixture |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
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