Submission Details
| 510(k) Number | K971958 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 28, 1997 |
| Decision Date | August 20, 1997 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
Aug 1997
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K971958 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 20, 1997, 84 days after receiving the submission on May 28, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.
Device Classification
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5880 |
Manufacturer
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