DEM — Alpha-1-Antitrypsin, Antigen, Antiserum, Control Class II
FDA product code DEM covers "Alpha-1-Antitrypsin, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5130. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DEM
- Device Class
- Class II
- Regulation Number
- 866.5130
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123256 | binding site group | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | July 3, 2013 |
| K063610 | dade behring | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL | January 11, 2007 |
| K053072 | dade behring | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | March 28, 2006 |
| K052819 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VER | December 23, 2005 |
| K050596 | biokit | QUANTIA A1-AT | May 13, 2005 |
| K031857 | bayer diagnostics | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | September 4, 2003 |
| K011663 | binding site | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | July 30, 2001 |
| K010978 | rochdiag | TINA-QUANT ALPHA-1 ANTITRYPSIN | May 18, 2001 |
| K993444 | kamiya biomedical | K-ASSAY ALPHA-1 AT | November 24, 1999 |
| K972640 | boehringer mannheim | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY | January 9, 1998 |
| K973391 | ventana medical systems | CHEMMATE KAPPA | October 3, 1997 |
| K973390 | ventana medical systems | CHEMMATE L26 (CD20) | October 3, 1997 |
| K973392 | ventana medical systems | CHEMMATE LAMBDA | October 3, 1997 |
| K973389 | ventana medical systems | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | October 3, 1997 |
| K965100 | crestat diagnostics | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | July 14, 1997 |
| K964766 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | April 25, 1997 |
| K931979 | ventana medical systems | VENTANA NEGATIVE CONTROL REAGENT | March 30, 1994 |
| K920005 | instrumentation laboratory | IL TEST ALPHA-1-ANTITRYPSIN (AAT) | July 29, 1992 |
| K913666 | binding site | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT | December 9, 1991 |
| K890415 | atlantic antibodies | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | February 17, 1989 |