FDA Product Code
FDA Product Code DEM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5130
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | The Binding Site Group , Ltd. | 2013-07-03 | Traditional | PDF ↗ |
| K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | 2007-01-11 | Traditional | PDF ↗ |
| K053072 | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | Dade Behring, Inc. | 2006-03-28 | Traditional | PDF ↗ |
| K052819 | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K050596 | QUANTIA A1-AT | Biokit, S.A. | 2005-05-13 | Traditional | PDF ↗ |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Bayer Diagnostics Corp. | 2003-09-04 | Traditional | PDF ↗ |
| K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | The Binding Site, Ltd. | 2001-07-30 | Traditional | PDF ↗ |
| K010978 | TINA-QUANT ALPHA-1 ANTITRYPSIN | Rochdiag | 2001-05-18 | Traditional | PDF ↗ |
| K993444 | K-ASSAY ALPHA-1 AT | Kamiya Biomedical Co. | 1999-11-24 | Traditional | PDF ↗ |
| K972640 | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY | Boehringer Mannheim Corp. | 1998-01-09 | Traditional | PDF ↗ |
| K973392 | CHEMMATE LAMBDA | Ventana Medical Systems, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | Ventana Medical Systems, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K973390 | CHEMMATE L26 (CD20) | Ventana Medical Systems, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K973391 | CHEMMATE KAPPA | Ventana Medical Systems, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | Beckman Instruments, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K931979 | VENTANA NEGATIVE CONTROL REAGENT | Ventana Medical Systems, Inc. | 1994-03-30 | Traditional | PDF ↗ |
| K920005 | IL TEST ALPHA-1-ANTITRYPSIN (AAT) | Instrumentation Laboratory CO | 1992-07-29 | Traditional | PDF ↗ |
| K913666 | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-09 | Traditional | PDF ↗ |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Atlantic Antibodies | 1989-02-17 | Traditional | PDF ↗ |
| K882446 | ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 | Traditional | PDF ↗ |
| K875281 | QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-02-10 | Traditional | PDF ↗ |
| K875283 | QM2/QM300 CONTROL B PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-02-10 | Traditional | PDF ↗ |
| K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN | Applications Lab | 1985-03-14 | Traditional | PDF ↗ |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | J.T. Baker Chemical Co. | 1980-09-16 | Traditional | PDF ↗ |
| K791605 | GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN | Protos Laboratories | 1979-09-04 | Traditional | PDF ↗ |
| K781408 | RID SYSTEM-(ACP) TEST | Icl Scientific | 1978-08-21 | Traditional | PDF ↗ |
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | Gelman Instrument Co. | 1978-02-03 | Traditional | PDF ↗ |
| K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1976-11-16 | Traditional | PDF ↗ |
| K760034 | TEST, STREP, LATEX SLIDE | Gamma Biologicals, Inc. | 1976-08-11 | Traditional | PDF ↗ |
Product code DEM · Class II · Immunology. Data: openFDA.