Roche Reagent for Apolipoprotein A-1
FDA 510(k) K910551 · Roche Diagnostic Systems, Inc.
510(k) numberK910551
Submission
- Device name
- Roche Reagent for Apolipoprotein A-1
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- February 7, 1991
- Decision date
- May 7, 1991
- 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 |
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| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Roche Reagent for Apolipoprotein A-1 cleared by the FDA?
Roche Reagent for Apolipoprotein A-1 (K910551) received a 510(k) decision of Substantially Equivalent on May 7, 1991, 89 days after the submission was received.
What is the product code of K910551?
The FDA product code is MSJ – Apolipoproteins, a Class I (low risk) device regulated under 21 CFR 862.1475.