Submission Details
| 510(k) Number | K142781 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2014 |
| Decision Date | March 31, 2015 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA
Mar 2015
Decision
186d
Days
Class 2
Risk
About This 510(k) Submission
K142781 is an FDA 510(k) clearance for the ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on March 31, 2015, 186 days after receiving the submission on September 26, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.
Device Classification
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |
Manufacturer
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