Submission Details
| 510(k) Number | K962235 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 1996 |
| Decision Date | June 26, 1996 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS SPECIALTY DILUENT
Jun 1996
Decision
15d
Days
Class 1
Risk
About This 510(k) Submission
K962235 is an FDA 510(k) clearance for the VITROS SPECIALTY DILUENT, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 26, 1996, 15 days after receiving the submission on June 11, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.
Device Classification
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2160 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
BRADFORD M SPRING
33 submissions
33 cleared
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