Submission Details
| 510(k) Number | K932658 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 1993 |
| Decision Date | July 28, 1993 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3
Jul 1993
Decision
56d
Days
Class 1
Risk
About This 510(k) Submission
K932658 is an FDA 510(k) clearance for the CKMB ISOENZYME CONTROL(HUMAN) LEVEL 1,2,& 3, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on July 28, 1993, 56 days after receiving the submission on June 2, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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