Submission Details
| 510(k) Number | K030701 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 06, 2003 |
| Decision Date | September 09, 2003 |
| Days to Decision | 187 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
Sep 2003
Decision
187d
Days
Class 2
Risk
About This 510(k) Submission
K030701 is an FDA 510(k) clearance for the IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 9, 2003, 187 days after receiving the submission on March 6, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.
Device Classification
| Product Code | MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
Manufacturer
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