BINDING SITE IGG SUBLCASS OLYMPUS KITS
FDA 510(k) clearance K042152 · decided 2004-11-22
Clearance details
- K-number
- K042152
- Device name
- BINDING SITE IGG SUBLCASS OLYMPUS KITS
- Applicant
- The Binding Site
- Decision
- Substantially Equivalent
- Date received
- 2004-08-09
- Decision date
- 2004-11-22
- Days to decision
- 105 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 Subclass Kit for use on the Beckman IMMAGE"/IMMAGE"800 Analyser Product Code LK009.I recall (Z-1067-2017) | The Binding Site Group, Ltd. | 2017-01-23 |
| Human lgG4 Subclass kit for use on the Beckman Coulter AU" series This kit is intended for recall (Z-1068-2017) | The Binding Site Group, Ltd. | 2017-01-23 |