FDA Product Code
FDA Product Code DEX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5420
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K823765 | ANTI SERA TO HUMAN OROSCOMUCOID | Kent Laboratories, Inc. | 1982-12-30 | Traditional | PDF ↗ |
| K801909 | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | J.T. Baker Chemical Co. | 1980-09-26 | Traditional | PDF ↗ |
| K791341 | HUMAN ALPHA, ACID GLYCOPROTEIN | Beckman Instruments, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K781023 | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | Icl Scientific | 1978-08-14 | Traditional | PDF ↗ |
| K760143 | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | Oxford Laboratories, Inc. | 1976-07-20 | Traditional | PDF ↗ |
Product code DEX · Class I · Immunology. Data: openFDA.