Submission Details
| 510(k) Number | K896686 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1989 |
| Decision Date | February 08, 1990 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
Cleared
Traditional
AMRESCO CREATININE REAGENT #4316100
Feb 1990
Decision
72d
Days
Class 2
Risk
About This 510(k) Submission
K896686 is an FDA 510(k) clearance for the AMRESCO CREATININE REAGENT #4316100, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on February 8, 1990, 72 days after receiving the submission on November 28, 1989. 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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