Submission Details
| 510(k) Number | K955286 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 1995 |
| Decision Date | May 17, 1996 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU)
May 1996
Decision
183d
Days
Class 2
Risk
About This 510(k) Submission
K955286 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY SLIDE GLUCOSE (GLU), a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 17, 1996, 183 days after receiving the submission on November 16, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
CHARLES C MORGANSON, JR.
33 submissions
33 cleared
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