Submission Details
| 510(k) Number | K002156 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2000 |
| Decision Date | December 19, 2000 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
APPRAISE URINE MICROALBUMIN COLLECTION KIT
Dec 2000
Decision
155d
Days
Class 2
Risk
About This 510(k) Submission
K002156 is an FDA 510(k) clearance for the APPRAISE URINE MICROALBUMIN COLLECTION KIT, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Osborn Group, Inc. (Olathe, US). The FDA issued a Cleared decision on December 19, 2000, 155 days after receiving the submission on July 17, 2000. 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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