LKL — Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control Class I
FDA product code LKL covers "Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5420. Submissions are reviewed by the Immunology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LKL
- 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 |
|---|---|---|---|
| K993441 | kamiya biomedical | K-ASSAY ALPHA-1 AG | November 24, 1999 |
| K964299 | crestat diagnostics | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K964257 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT | March 24, 1997 |
| K922417 | binding site | AL-ACID GLYCOPROTEIN RID KIT | August 20, 1992 |
| K904175 | reagents applications | RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT | November 13, 1990 |
| K884217 | technicon instruments | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | November 4, 1988 |
| K873868 | unipath | ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) | October 20, 1987 |
| K862087 | scientific sales intl | SANTEST 1AP | December 3, 1986 |
| K861336 | scientific sales intl | IAP PLATE TEST | April 25, 1986 |
| K841734 | tago | TAGO FIFFU-GEN, OROSOMUCOID | June 1, 1984 |
| K831960 | kent laboratories | TEST FOR HUMAN ALPHA ONE ACID GLYCO- | July 19, 1983 |