Submission Details
| 510(k) Number | K961196 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 27, 1996 |
| Decision Date | May 15, 1996 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
May 1996
Decision
49d
Days
Class 2
Risk
About This 510(k) Submission
K961196 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA), a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 15, 1996, 49 days after receiving the submission on March 27, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.
Device Classification
| Product Code | CDN — Urease, Photometric, Urea Nitrogen |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1770 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
CHARLES C MORGANSON
33 submissions
33 cleared
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