FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT— 510(k) K070900
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K070900 for FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT, Substantially Equivalent on 2007-11-30. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code DFH
- Device class
- Class 2
- Regulation
- 21 CFR 866.5550
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
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More clearances from The Binding Site, Ltd.
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Recalls naming K070900
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070900.
Data sourced from openFDA. This site is unofficial and independent of the FDA.