Submission Details
| 510(k) Number | K092601 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 24, 2009 |
| Decision Date | October 07, 2010 |
| Days to Decision | 409 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ANCA SCREEN ELISA
Oct 2010
Decision
409d
Days
Class 2
Risk
About This 510(k) Submission
K092601 is an FDA 510(k) clearance for the IMMULISA ANCA SCREEN ELISA, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 7, 2010, 409 days after receiving the submission on August 24, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.
Device Classification
| Product Code | MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
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