MSJ · Apolipoproteins
Clinical Chemistry · 21 CFR 862.1475 · Class 1
Overview
| Product Code | MSJ |
|---|---|
| Device Name | Apolipoproteins |
| Regulation | 21 CFR 862.1475 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 50)
Showing 20 most recent of 50 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | General Atomics | Jul 16, 2008 | SESE |
| K073488 | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | Diazyme Laboratories | Mar 7, 2008 | SESE |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Pointe Scientific, Inc., | Mar 28, 2007 | SESE |
| K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | Feb 23, 2007 | SESE |
| K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Bayer Corp. | Feb 15, 2000 | SESE |
| K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | Beckman Instruments, Inc. | Apr 21, 1997 | SESE |
| K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | Beckman Instruments, Inc. | Feb 10, 1997 | SESE |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | Nichols Institute | Aug 16, 1993 | SESE |
| K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | Dec 23, 1992 | SESE |
| K923087 | IL TEST APOLIPOPROTEIN A1 | Instrumentation Laboratory CO | Oct 26, 1992 | SESE |
| K923080 | IL TEST APOLIPOROTEIN B (APO B) | Instrumentation Laboratory CO | Oct 26, 1992 | SESE |
| K921795 | BACTON(TM), AUTO-APO A-1 REAGENT | Bacton Assay Systems, Inc. | Jun 23, 1992 | SESE |
| K921862 | BACTON(TM), AUTO-APO B REAGENT | Bacton Assay Systems, Inc. | Jun 22, 1992 | SESE |
| K921037 | APOLIPOPROTEIN TEST SYSTEM | Baxter Diagnostics, Inc. | May 22, 1992 | SESE |
| K914069 | REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 | Medical Analysis Systems, Inc. | Oct 2, 1991 | SESE |
| K912749 | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B | Medical Analysis Systems, Inc. | Sep 23, 1991 | SESE |
| K910552 | ROCHE REAGENT FOR APOLIPOPROTEIN B | Roche Diagnostic Systems, Inc. | May 7, 1991 | SESE |
| K910551 | ROCHE REAGENT FOR APOLIPOPROTEIN A-1 | Roche Diagnostic Systems, Inc. | May 7, 1991 | SESE |
| K895277 | ORTHO APO B ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | Sep 27, 1989 | SESE |
| K893884 | BACTON TM, BASIC TM, APO B REAGENT | Catachem, Inc. | Jun 21, 1989 | SESE |
Top Applicants
- Atlantic Antibodies — 4 clearances
- Beckman Instruments, Inc. — 4 clearances
- Bacton Assay Systems, Inc. — 2 clearances
- Instrumentation Laboratory CO — 2 clearances
- Intl. Diagnostic Laboratories, Ltd. — 2 clearances
