LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
FDA 510(k) clearance K853261 · decided 1985-08-22
Clearance details
- K-number
- K853261
- Device name
- LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
- Applicant
- Behring Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-02
- Decision date
- 1985-08-22
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- CZS
- Device class
- 1
- Regulation number
- 866.5765
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- La Jolla, 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 PROTEIN RBP RID KIT (K973189) | The Binding Site, Ltd. | 1997-09-29 |
| RETINOL BINDING RID KIT (K955881) | The Binding Site, Ltd. | 1996-03-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OPUS(R) CEA TEST SYSTEM (P920021/S001) | Behring Diagnostics, Inc. | 1996-02-23 |