Submission Details
| 510(k) Number | K041102 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 27, 2004 |
| Decision Date | October 26, 2004 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA
Oct 2004
Decision
182d
Days
Class 2
Risk
About This 510(k) Submission
K041102 is an FDA 510(k) clearance for the IMMULISA ANTINUCLEAR ANTIBODY SCREEN 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 October 26, 2004, 182 days after receiving the submission on April 27, 2004. 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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