Submission Details
| 510(k) Number | K863079 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 12, 1986 |
| Decision Date | December 12, 1986 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
CREATINKINETIC
Dec 1986
Decision
122d
Days
Class 2
Risk
About This 510(k) Submission
K863079 is an FDA 510(k) clearance for the CREATINKINETIC, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on December 12, 1986, 122 days after receiving the submission on August 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.
Device Classification
| Product Code | CGX — Alkaline Picrate, Colorimetry, Creatinine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
Manufacturer
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