Submission Details
| 510(k) Number | K973743 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 01, 1997 |
| Decision Date | October 31, 1997 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Oct 1997
Decision
30d
Days
Class 1
Risk
About This 510(k) Submission
K973743 is an FDA 510(k) clearance for the ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on October 31, 1997, 30 days after receiving the submission on October 1, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1260.
Device Classification
| Product Code | CHP — Radioimmunoassay, Estradiol |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1260 |
Manufacturer
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