Submission Details
| 510(k) Number | K964982 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 12, 1996 |
| Decision Date | February 20, 1997 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
Feb 1997
Decision
70d
Days
Class 1
Risk
About This 510(k) Submission
K964982 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55), a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 20, 1997, 70 days after receiving the submission on December 12, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.
Device Classification
| Product Code | CEP — Radioimmunoassay, Luteinizing Hormone |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1485 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
ANN M QUINN
33 submissions
33 cleared
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