Submission Details
| 510(k) Number | K962919 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 26, 1996 |
| Decision Date | October 18, 1996 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS IMMUNODIAGNOSTIC SYSTEM
Oct 1996
Decision
84d
Days
Class 1
Risk
About This 510(k) Submission
K962919 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC SYSTEM, a Fluorometer, For Clinical Use (Class I — General Controls, product code KHO), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on October 18, 1996, 84 days after receiving the submission on July 26, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2560.
Device Classification
| Product Code | KHO — Fluorometer, For Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2560 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
CHARLES C MORGANSON, JR.
33 submissions
33 cleared
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