Submission Details
| 510(k) Number | K974050 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 1997 |
| Decision Date | November 24, 1997 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT
Nov 1997
Decision
31d
Days
Class 2
Risk
About This 510(k) Submission
K974050 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on November 24, 1997, 31 days after receiving the submission on October 24, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.
Device Classification
| Product Code | DCK — C-reactive Protein, Antigen, Antiserum, And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5270 |
Manufacturer
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