Submission Details
| 510(k) Number | K973928 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 1997 |
| Decision Date | December 01, 1997 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
Dec 1997
Decision
47d
Days
Class 2
Risk
About This 510(k) Submission
K973928 is an FDA 510(k) clearance for the BECKMAN URINE PROTEIN CALIBRATOR (UCAL), 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 December 1, 1997, 47 days after receiving the submission on October 15, 1997. This device falls under the Chemistry 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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