J.T. Baker ALPHA-1-ANTITRYPSIN Nephelo
FDA 510(k) K801669 · J.T. Baker Chemical Co.
510(k) numberK801669
Submission
- Device name
- J.T. Baker ALPHA-1-ANTITRYPSIN Nephelo
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- July 22, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K803128 | Series 810 Platelet AnalyzerGKL · Traditional | 04/03/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | 10/10/1980SE |
| K802035 | Baker Diag. Ultrarate CO2 Reagent KitJFL · Traditional | 09/26/1980SE |
| K801909 | Lsa 290 Assay Reagents/NephelometricDEX · Traditional | 09/26/1980SE |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | 09/16/1980SE |
| K801662 | J.T. Baker ALPHA-2-MACROGLOBULIN Neph.DEP · Traditional | 09/16/1980SE |
| K801661 | J.T. Baker Ceruloplasmin NephelometricDDB · Traditional | 09/16/1980SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | 07/21/1980SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | 07/08/1980SE |
| K801433 | Haptoglobin Nephelometric AssayDAD · Traditional | 07/08/1980SE |
Questions and answers
When was J.T. Baker ALPHA-1-ANTITRYPSIN Nephelo cleared by the FDA?
J.T. Baker ALPHA-1-ANTITRYPSIN Nephelo (K801669) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 56 days after the submission was received.
What is the product code of K801669?
The FDA product code is DEM – Alpha-1-Antitrypsin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5130.