Submission Details
| 510(k) Number | K083188 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 29, 2008 |
| Decision Date | March 13, 2009 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
Mar 2009
Decision
135d
Days
Class 2
Risk
About This 510(k) Submission
K083188 is an FDA 510(k) clearance for the VARELISA RECOMBI ANA SCREEN, MODEL 12 596, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Phadia US, Inc. (Portae, US). The FDA issued a Cleared decision on March 13, 2009, 135 days after receiving the submission on October 29, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
Similar Devices — LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
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