Submission Details
| 510(k) Number | K113143 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 25, 2011 |
| Decision Date | December 02, 2011 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA SCI-70 ANTIBODY ELISA
Dec 2011
Decision
38d
Days
Class 2
Risk
About This 510(k) Submission
K113143 is an FDA 510(k) clearance for the IMMULISA SCI-70 ANTIBODY ELISA, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on December 2, 2011, 38 days after receiving the submission on October 25, 2011. 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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