Submission Details
| 510(k) Number | K970281 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 24, 1997 |
| Decision Date | February 25, 1997 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS
Feb 1997
Decision
32d
Days
Class 1
Risk
About This 510(k) Submission
K970281 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS, a Radioimmunoassay, Prolactin (lactogen) (Class I — General Controls, product code CFT), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 25, 1997, 32 days after receiving the submission on January 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1625.
Device Classification
| Product Code | CFT — Radioimmunoassay, Prolactin (lactogen) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1625 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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