Immage Immunochemistry System ALPHA-1-ANTITRYPSIN (Aat)
FDA 510(k) K964766 · Beckman Instruments, Inc.
510(k) numberK964766
Submission
- Device name
- Immage Immunochemistry System ALPHA-1-ANTITRYPSIN (Aat)
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- November 27, 1996
- Decision date
- April 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5130
- Specialty
- Immunology
Other 510(k)s with product code DEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123256 | Human ALPHA-1 Antitrypsin Kit SpaplusDEM · Traditional | The Binding Site Group , Ltd. | 07/03/2013SE |
| K063610 | Dimension Vista A1AT Flex Reagent Cartridge and Protein 1 Calibrator and Control Medium…DEM · Traditional | Dade Behring, Inc. | 01/11/2007SE |
| K053072 | N Antisera to Human ALPHA1-ANTITRYPSINDEM · Traditional | Dade Behring, Inc. | 03/28/2006SE |
| K052819 | Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers…DEM · Traditional | Ortho-Clinical Diagnostics, Inc. | 12/23/2005SE |
| K050596 | Quantia A1-ATDEM · Traditional | Biokit, S.A. | 05/13/2005SE |
| K031857 | Advia Chemistry ALPHA-1 Antitrypsin AssayDEM · Traditional | Bayer Diagnostics Corp. | 09/04/2003SE |
| K011663 | Minineph A-1 Antitrypsin Antiserum, High and Low Serum ControlsDEM · Traditional | The Binding Site, Ltd. | 07/30/2001SE |
| K010978 | Tina-Quant ALPHA-1 AntitrypsinDEM · Traditional | Rochdiag | 05/18/2001SE |
| K993444 | K-Assay ALPHA-1 atDEM · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K972640 | Tina-Quant Alpha PARTICLE-1-ANTITRYPSIN AssayDEM · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
More from Boehringer Mannheim Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K973448 | Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465…LGD · Traditional | 09/17/1998SE |
| K982250 | Access Free T4 Reagents on the Access Immunoassay AnalyzerCEC · Traditional | 07/14/1998SE |
| K981403 | Immage Immunochemistry System Valproic Acid (Vpa) ReagentDKB · Traditional | 05/08/1998SE |
| K981354 | Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211LOJ · Traditional | 05/01/1998SE |
| K980173 | Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505JHI · Traditional | 03/18/1998SE |
| K974816 | Access(R) Psa Reagents on the Access(R) Immunoassay Analyzer 33220, 33225, 33229LTJ · Traditional | 02/20/1998SE |
| K974564 | Immage Immunochemistry System ALPHA-2-MACROGLOBULIN ReagentDEB · Traditional | 02/17/1998SE |
| K974110 | Immage Immunochemistry System Antithrombin III (AT3) ReagentJBQ · Traditional | 12/24/1997SE |
| K974452 | Vigil Lipid ControlJJY · Traditional | 12/17/1997SE |
| K973932 | Beckman Calibrator 2 (CAL2)JIX · Traditional | 12/15/1997SE |
Questions and answers
When was Immage Immunochemistry System ALPHA-1-ANTITRYPSIN (Aat) cleared by the FDA?
Immage Immunochemistry System ALPHA-1-ANTITRYPSIN (Aat) (K964766) received a 510(k) decision of Substantially Equivalent on April 25, 1997, 149 days after the submission was received.
What is the product code of K964766?
The FDA product code is DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5130.