BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT— 510(k) K991802
Substantially EquivalentThe Binding Site, Ltd.
FDA 510(k) clearance K991802 for BINDAZYME ANTI-B2 GP1 IGA EIA TEST KIT, Substantially Equivalent on 2000-05-05. Applicant: The Binding Site, Ltd.. Device class: 2.
Clearance details
- Applicant
- The Binding Site, Ltd.
- Product code
- Code MSV
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Monica, CA, US
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- K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
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Data sourced from openFDA. This site is unofficial and independent of the FDA.