DEX — Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control Class I
FDA product code DEX covers "Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5420. Submissions are reviewed by the Immunology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DEX
- Device Class
- Class I
- Regulation Number
- 866.5420
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K823765 | kent laboratories | ANTI SERA TO HUMAN OROSCOMUCOID | December 30, 1982 |
| K801909 | j.t. baker chemical | LSA 290 ASSAY REAGENTS/NEPHELOMETRIC | September 26, 1980 |
| K791341 | beckman instruments | HUMAN ALPHA, ACID GLYCOPROTEIN | August 16, 1979 |
| K781023 | icl scientific | ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU | August 14, 1978 |
| K760143 | oxford laboratories | SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN | July 20, 1976 |