Submission Details
| 510(k) Number | K071247 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 2007 |
| Decision Date | August 08, 2007 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
N LATEX RF KIT
Aug 2007
Decision
96d
Days
Class 2
Risk
About This 510(k) Submission
K071247 is an FDA 510(k) clearance for the N LATEX RF KIT, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 8, 2007, 96 days after receiving the submission on May 4, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.
Device Classification
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5775 |
Manufacturer
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