Submission Details
| 510(k) Number | K961099 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 1996 |
| Decision Date | May 07, 1996 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
May 1996
Decision
49d
Days
Class 2
Risk
About This 510(k) Submission
K961099 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+), a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 7, 1996, 49 days after receiving the submission on March 19, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.
Device Classification
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1665 |
Manufacturer
Johnson & Johnson Clinical Diagnostics, Inc.
Rochester, NY · US
CHARLES C MORGANSON, JR.
33 submissions
33 cleared
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