Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx
FDA 510(k) K073488 · Diazyme Laboratories
510(k) numberK073488
Submission
- Device name
- Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- October 22, 2007
- Decision date
- March 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSJ – Apolipoproteins
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | General Atomics | 07/16/2008SE |
| 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 |
| K923080 | Il Test Apoliporotein B (Apo B)MSJ · Traditional | Instrumentation Laboratory CO | 10/26/1992SE |
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Questions and answers
When was Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx cleared by the FDA?
Diazyme Apolipoprotein B Assay, Model Dzxxx-X; B Calibrator, Model Dzxxx (K073488) received a 510(k) decision of Substantially Equivalent on March 7, 2008, 137 days after the submission was received.
What is the product code of K073488?
The FDA product code is MSJ – Apolipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.