Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
FDA product code LKL · Class I (low risk) · 21 CFR 866.5420 · Immunology
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993441 | K-Assay ALPHA-1 AGLKL · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K964299 | N-Assay Tia Multi V-NlLKL · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K964257 | Immage Immunochemistry System ALPHA-1-ACID Glycoprotein (Aag) ReagentLKL · Traditional | Beckman Instruments, Inc. | 03/24/1997SE |
| K922417 | Al-Acid Glycoprotein Rid KitLKL · Traditional | The Binding Site, Ltd. | 08/20/1992SE |
| K904175 | Raichem (TM) Spia (TM) - Acid Glycoprotein ReagentLKL · Traditional | Reagents Applications, Inc. | 11/13/1990SE |
| K884217 | Technicon DPA-1 Analyte Alpha 1 Acid GlycoproteinLKL · Traditional | Technicon Instruments Corp. | 11/04/1988SE |
| K873868 | ALPHA-1-ACID Glycoprotein (Orosomucoid)LKL · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K862087 | Santest 1APLKL · Traditional | Scientific Sales Intl., Inc. | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | Scientific Sales Intl., Inc. | 04/25/1986SE |
| K841734 | Tago Fiffu-Gen, OrosomucoidLKL · Traditional | Tago, Inc. | 06/01/1984SE |
| K831960 | Test for Human Alpha One Acid Glyco-LKL · Traditional | Kent Laboratories, Inc. | 07/19/1983SE |