Submission Details
| 510(k) Number | K231290 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 2023 |
| Decision Date | January 24, 2024 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
Cleared
Traditional
Optilite? Freelite? Kappa Free Kit, Optilite? Freelite? Lambda Free Kit
Jan 2024
Decision
265d
Days
Class 2
Risk
About This 510(k) Submission
K231290 is an FDA 510(k) clearance for the Optilite? Freelite? Kappa Free Kit, Optilite? Freelite? Lambda Free Kit, a Kappa, Antigen, Antiserum, Control (Class II — Special Controls, product code DFH), submitted by The Binding Site, Ltd. (Birmingham, GB). The FDA issued a Cleared decision on January 24, 2024, 265 days after receiving the submission on May 4, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.
Device Classification
| Product Code | DFH — Kappa, Antigen, Antiserum, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5550 |
Manufacturer
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