Submission Details
| 510(k) Number | K970643 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 20, 1997 |
| Decision Date | March 18, 1997 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
Mar 1997
Decision
26d
Days
Class 1
Risk
About This 510(k) Submission
K970643 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050), a Radioimmunoassay, Estradiol (Class I — General Controls, product code CHP), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 18, 1997, 26 days after receiving the submission on February 20, 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
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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