Submission Details
| 510(k) Number | K101319 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 11, 2010 |
| Decision Date | December 09, 2010 |
| Days to Decision | 212 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA DSDNA ANTIBODY ELISA
Dec 2010
Decision
212d
Days
Class 2
Risk
About This 510(k) Submission
K101319 is an FDA 510(k) clearance for the IMMULISA DSDNA ANTIBODY ELISA, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on December 9, 2010, 212 days after receiving the submission on May 11, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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