Submission Details
| 510(k) Number | K972133 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 1997 |
| Decision Date | June 24, 1997 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
Jun 1997
Decision
18d
Days
Class 1
Risk
About This 510(k) Submission
K972133 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070), a Radioimmunoassay, Progesterone (Class I — General Controls, product code JLS), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 24, 1997, 18 days after receiving the submission on June 6, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1620.
Device Classification
| Product Code | JLS — Radioimmunoassay, Progesterone |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1620 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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