LKL
11 FDA 510(k) clearances · Product code
57 daysmedian time to decision
184 days90th percentile
11clearances measured
FDA profile
- Official device name
- Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5420
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| K-ASSAY ALPHA-1 AG (K993441) | Kamiya Biomedical Co. | 1999-11-24 |
| N-ASSAY TIA MULTI V-NL (K964299) | Crestat Diagnostics, Inc. | 1997-07-14 |
| IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT (K964257) | Beckman Instruments, Inc. | 1997-03-24 |
| AL-ACID GLYCOPROTEIN RID KIT (K922417) | The Binding Site, Ltd. | 1992-08-20 |
| RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT (K904175) | Reagents Applications, Inc. | 1990-11-13 |
| TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (K884217) | Technicon Instruments Corp. | 1988-11-04 |
| ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (K873868) | Unipath , Ltd. | 1987-10-20 |
| SANTEST 1AP (K862087) | Scientific Sales Intl., Inc. | 1986-12-03 |
| IAP PLATE TEST (K861336) | Scientific Sales Intl., Inc. | 1986-04-25 |
| TAGO FIFFU-GEN, OROSOMUCOID (K841734) | Tago, Inc. | 1984-06-01 |
| TEST FOR HUMAN ALPHA ONE ACID GLYCO- (K831960) | Kent Laboratories, Inc. | 1983-07-19 |
Track LKL automatically
Every clearance here is in the API, with alerts when new ones post.