Apolipoprotein for the Technicon DPA-1(TM) System
FDA 510(k) K882620 · Technicon Instruments Corp.
510(k) numberK882620
Submission
- Device name
- Apolipoprotein for the Technicon DPA-1(TM) System
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- June 24, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MSJ – Apolipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | General Atomics | 07/16/2008SE |
| K073488 | Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model DzxxxMSJ · Traditional | Diazyme Laboratories | 03/07/2008SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | Pointe Scientific, Inc., | 03/28/2007SE |
| K063608 | Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…MSJ · Traditional | Dade Behring, Inc. | 02/23/2007SE |
| K992662 | 8 Additional Assays for the Bayer Advia 1650 Chemistry SystemMSJ · Traditional | Bayer Corp. | 02/15/2000SE |
| K970314 | Synchron LX Systems Apolipoprotein (Apoa and Apob) ReagentsMSJ · Traditional | Beckman Instruments, Inc. | 04/21/1997SE |
| K964010 | Immage Immunochemistry System Apolipoprotein A-1 Reagent (Apa)/ Immage Immunochemistry…MSJ · Traditional | Beckman Instruments, Inc. | 02/10/1997SE |
| K931777 | Apo A-1 Chemiluminescence AssayMSJ · Traditional | Nichols Institute | 08/16/1993SE |
| K925702 | Nichols Apo B Chemiluminescence AssayMSJ · Traditional | Nichols Institute Diagnostics | 12/23/1992SE |
| K923087 | Il Test Apolipoprotein A1MSJ · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Apolipoprotein for the Technicon DPA-1(TM) System cleared by the FDA?
Apolipoprotein for the Technicon DPA-1(TM) System (K882620) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 14 days after the submission was received.
What is the product code of K882620?
The FDA product code is MSJ – Apolipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.