HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
FDA 510(k) clearance K090920 · decided 2009-12-30
Clearance details
- K-number
- K090920
- Device name
- HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-04-01
- Decision date
- 2009-12-30
- Days to decision
- 273 days
- Clearance type
- Traditional
- Product code
- CFN
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent recall (Z-1070-2017) | The Binding Site Group, Ltd. | 2017-01-23 |