Submission Details
| 510(k) Number | K082129 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 29, 2008 |
| Decision Date | February 10, 2009 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
Cleared
Traditional
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
Feb 2009
Decision
196d
Days
Class 2
Risk
About This 510(k) Submission
K082129 is an FDA 510(k) clearance for the HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER, 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 February 10, 2009, 196 days after receiving the submission on July 29, 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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