510(k) K972640
- Device
- TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
- Applicant
- BOEHRINGER MANNHEIM CORP.
- 510(k) number
- K972640
- Product code
- DEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-01-09
- Date received
- 1997-07-15
- Regulation
- 866.5130
- Classification name
- Alpha-1-antitrypsin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARY KONING
- Address
- 2380a Bisso Ln. Concord CA US 94520 94520
FDA Registration Numbers#
- 2084025
- 3006198300
- 3003795116
- 9610806
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 1319808
- 1000403749
- 2517506
- 9610746
- 3019906
- 3004493545
- 3002642396
- 2050010
- 3012471076
- 9610126
- 1319681
- 3000308930
- 9614373
Source Documents#
Other 510(k) Records For Product Code DEM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | The Binding Site Group , Ltd. | 2013-07-03 |
| K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | 2007-01-11 |
| K053072 | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | Dade Behring, Inc. | 2006-03-28 |
| K052819 | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2005-12-23 |
| K050596 | QUANTIA A1-AT | Biokit, S.A. | 2005-05-13 |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Bayer Diagnostics Corp. | 2003-09-04 |
| K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | The Binding Site, Ltd. | 2001-07-30 |
| K010978 | TINA-QUANT ALPHA-1 ANTITRYPSIN | Rochdiag | 2001-05-18 |
| K993444 | K-ASSAY ALPHA-1 AT | Kamiya Biomedical Co. | 1999-11-24 |
| K973392 | CHEMMATE LAMBDA | Ventana Medical Systems, Inc. | 1997-10-03 |
| K973391 | CHEMMATE KAPPA | Ventana Medical Systems, Inc. | 1997-10-03 |
| K973390 | CHEMMATE L26 (CD20) | Ventana Medical Systems, Inc. | 1997-10-03 |
| K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | Ventana Medical Systems, Inc. | 1997-10-03 |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 |
| K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | Beckman Instruments, Inc. | 1997-04-25 |
Legacy Summary#
summary
FDA Review#
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