Submission Details
| 510(k) Number | K073055 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 30, 2007 |
| Decision Date | January 03, 2008 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
Jan 2008
Decision
65d
Days
Class 2
Risk
About This 510(k) Submission
K073055 is an FDA 510(k) clearance for the DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270, a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 3, 2008, 65 days after receiving the submission on October 30, 2007. 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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