RETINOL BINDING PROTEIN RBP RID KIT
FDA 510(k) clearance K973189 · decided 1997-09-29
Clearance details
- K-number
- K973189
- Device name
- RETINOL BINDING PROTEIN RBP RID KIT
- Applicant
- The Binding Site, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-25
- Decision date
- 1997-09-29
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- CZS
- Device class
- 1
- Regulation number
- 866.5765
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Santa Monica, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RETINOL BINDING RID KIT (K955881) | The Binding Site, Ltd. | 1996-03-22 |
| LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) (K853261) | Behring Diagnostics, Inc. | 1985-08-22 |
Recalls involving this device
No recalls on record reference this clearance.