FDA Product Code
FDA Product Code LKL — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5420
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993441 | K-ASSAY ALPHA-1 AG | Kamiya Biomedical Co. | 1999-11-24 | Traditional | PDF ↗ |
| K964299 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K964257 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | Beckman Instruments, Inc. | 1997-03-24 | Traditional | PDF ↗ |
| K922417 | AL-ACID GLYCOPROTEIN RID KIT | The Binding Site, Ltd. | 1992-08-20 | Traditional | PDF ↗ |
| K904175 | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | Reagents Applications, Inc. | 1990-11-13 | Traditional | PDF ↗ |
| K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | Technicon Instruments Corp. | 1988-11-04 | Traditional | PDF ↗ |
| K873868 | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | Unipath , Ltd. | 1987-10-20 | Traditional | PDF ↗ |
| K862087 | SANTEST 1AP | Scientific Sales Intl., Inc. | 1986-12-03 | Traditional | PDF ↗ |
| K861336 | IAP PLATE TEST | Scientific Sales Intl., Inc. | 1986-04-25 | Traditional | PDF ↗ |
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | Tago, Inc. | 1984-06-01 | Traditional | PDF ↗ |
| K831960 | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | Kent Laboratories, Inc. | 1983-07-19 | Traditional | PDF ↗ |
Product code LKL · Class I · Immunology. Data: openFDA.