Submission Details
| 510(k) Number | K071767 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 29, 2007 |
| Decision Date | August 04, 2007 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A
Aug 2007
Decision
36d
Days
Class 2
Risk
About This 510(k) Submission
K071767 is an FDA 510(k) clearance for the DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on August 4, 2007, 36 days after receiving the submission on June 29, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1117.
Device Classification
| Product Code | NBC — Test, Natriuretic Peptide |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1117 |
Manufacturer
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