Submission Details
| 510(k) Number | K071834 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 03, 2007 |
| Decision Date | August 17, 2007 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM
Aug 2007
Decision
45d
Days
Class 2
Risk
About This 510(k) Submission
K071834 is an FDA 510(k) clearance for the STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM, a Test, Natriuretic Peptide (Class II — Special Controls, product code NBC), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 17, 2007, 45 days after receiving the submission on July 3, 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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