Submission Details
| 510(k) Number | K102673 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 2010 |
| Decision Date | September 30, 2011 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Sep 2011
Decision
379d
Days
Class 2
Risk
About This 510(k) Submission
K102673 is an FDA 510(k) clearance for the RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on September 30, 2011, 379 days after receiving the submission on September 16, 2010. 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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