Submission Details
| 510(k) Number | K113610 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2011 |
| Decision Date | July 09, 2012 |
| Days to Decision | 216 days |
| Submission Type | Special |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Special
ANA-SCREEN WITH MDSS
Jul 2012
Decision
216d
Days
Class 2
Risk
About This 510(k) Submission
K113610 is an FDA 510(k) clearance for the ANA-SCREEN WITH MDSS, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on July 9, 2012, 216 days after receiving the submission on December 6, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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