Submission Details
| 510(k) Number | K081827 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 27, 2008 |
| Decision Date | December 19, 2008 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
Dec 2008
Decision
175d
Days
Class 2
Risk
About This 510(k) Submission
K081827 is an FDA 510(k) clearance for the HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on December 19, 2008, 175 days after receiving the submission on June 27, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.
Device Classification
| Product Code | CFN — Method, Nephelometric, Immunoglobulins (g, A, M) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
Manufacturer
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