Submission Details
| 510(k) Number | K964720 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 1996 |
| Decision Date | February 04, 1997 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)
Feb 1997
Decision
71d
Days
Class 1
Risk
About This 510(k) Submission
K964720 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005), a Radioimmunoassay, Follicle-stimulating Hormone (Class I — General Controls, product code CGJ), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 4, 1997, 71 days after receiving the submission on November 25, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1300.
Device Classification
| Product Code | CGJ — Radioimmunoassay, Follicle-stimulating Hormone |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1300 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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