Submission Details
| 510(k) Number | K032564 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 20, 2003 |
| Decision Date | October 31, 2003 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
Oct 2003
Decision
72d
Days
Class 2
Risk
About This 510(k) Submission
K032564 is an FDA 510(k) clearance for the DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111, a Enzyme Immunoassay, N-acetylprocainamide (Class II — Special Controls, product code LAN), submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on October 31, 2003, 72 days after receiving the submission on August 20, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.
Device Classification
| Product Code | LAN — Enzyme Immunoassay, N-acetylprocainamide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3320 |
Manufacturer
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