Submission Details
| 510(k) Number | K032796 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 08, 2003 |
| Decision Date | January 13, 2004 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
IBL C3D-CIC EIA TEST
Jan 2004
Decision
127d
Days
Class 2
Risk
About This 510(k) Submission
K032796 is an FDA 510(k) clearance for the IBL C3D-CIC EIA TEST, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on January 13, 2004, 127 days after receiving the submission on September 8, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.
Device Classification
| Product Code | CZW — Complement C3, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5240 |
Manufacturer
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