Submission Details
| 510(k) Number | K061775 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 2006 |
| Decision Date | February 23, 2007 |
| Days to Decision | 245 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
Feb 2007
Decision
245d
Days
Class 2
Risk
About This 510(k) Submission
K061775 is an FDA 510(k) clearance for the WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on February 23, 2007, 245 days after receiving the submission on June 23, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.
Device Classification
| Product Code | JFY — Enzymatic Method, Creatinine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1225 |
Manufacturer
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