Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and III
FDA 510(k) K052819 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK052819
Submission
- Device name
- Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and III
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- October 4, 2005
- Decision date
- December 23, 2005
- 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 |
| 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 |
| K973392 | Chemmate LambdaDEM · Traditional | Ventana Medical Systems, Inc. | 10/03/1997SE |
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Questions and answers
When was Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and III cleared by the FDA?
Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and III (K052819) received a 510(k) decision of Substantially Equivalent on December 23, 2005, 80 days after the submission was received.
What is the product code of K052819?
The FDA product code is DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5130.