Submission Details
| 510(k) Number | K131330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 08, 2013 |
| Decision Date | January 28, 2014 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
Jan 2014
Decision
265d
Days
Class 2
Risk
About This 510(k) Submission
K131330 is an FDA 510(k) clearance for the GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on January 28, 2014, 265 days after receiving the submission on May 8, 2013. 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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