Submission Details
| 510(k) Number | K151559 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 10, 2015 |
| Decision Date | March 11, 2016 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
ImmuLisa Enhanced Centromere Antibody ELISA
Mar 2016
Decision
275d
Days
Class 2
Risk
About This 510(k) Submission
K151559 is an FDA 510(k) clearance for the ImmuLisa Enhanced Centromere Antibody ELISA, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 11, 2016, 275 days after receiving the submission on June 10, 2015. 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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