Submission Details
| 510(k) Number | K973966 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 17, 1997 |
| Decision Date | October 31, 1997 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Oct 1997
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K973966 is an FDA 510(k) clearance for the ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, a Radioimmunoassay, Total Triiodothyronine (Class II — Special Controls, product code CDP), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on October 31, 1997, 14 days after receiving the submission on October 17, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1710.
Device Classification
| Product Code | CDP — Radioimmunoassay, Total Triiodothyronine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1710 |
Manufacturer
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