ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
FDA 510(k) clearance K781023 · decided 1978-08-14
Clearance details
- K-number
- K781023
- Device name
- ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
- Applicant
- Icl Scientific
- Decision
- Substantially Equivalent
- Date received
- 1978-06-19
- Decision date
- 1978-08-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- DEX
- Device class
- 1
- Regulation number
- 866.5420
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Icl Scientific
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ANTI SERA TO HUMAN OROSCOMUCOID (K823765) | Kent Laboratories, Inc. | 1982-12-30 |
| 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 |
| SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN (K760143) | Oxford Laboratories, Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.