Submission Details
| 510(k) Number | K980283 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 1998 |
| Decision Date | February 25, 1998 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
Feb 1998
Decision
30d
Days
Class 2
Risk
About This 510(k) Submission
K980283 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CRBM SLIDES, a Enzyme Immunoassay, Carbamazepine (Class II — Special Controls, product code KLT), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 25, 1998, 30 days after receiving the submission on January 26, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.
Device Classification
| Product Code | KLT — Enzyme Immunoassay, Carbamazepine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3645 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
CHARLES C MORGANSON
33 submissions
33 cleared
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