ANTI SERA TO HUMAN OROSCOMUCOID
FDA 510(k) clearance K823765 · decided 1982-12-30
Clearance details
- K-number
- K823765
- Device name
- ANTI SERA TO HUMAN OROSCOMUCOID
- Applicant
- Kent Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-14
- Decision date
- 1982-12-30
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- DEX
- Device class
- 1
- Regulation number
- 866.5420
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Walker, MI, 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 |
|---|---|---|
| LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (K801909) | J.T. Baker Chemical Co. | 1980-09-26 |
| HUMAN ALPHA, ACID GLYCOPROTEIN (K791341) | Beckman Instruments, Inc. | 1979-08-16 |
| ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU (K781023) | Icl Scientific | 1978-08-14 |
| SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (K760143) | Oxford Laboratories, Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.