FDA product code MSJ: Apolipoproteins
MSJ is the FDA product code for apolipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 50 510(k) submissions under MSJ, from 32 different applicants. The average 510(k) review took 87 days (median 71).
Classification
| Field | Value |
|---|---|
| Device name | Apolipoproteins |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MSJ clearance
Top MSJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Instruments, Inc. | 4 | 1997-04-21 |
| Atlantic Antibodies | 4 | 1989-03-16 |
| Instrumentation Laboratory CO | 2 | 1992-10-26 |
| Bacton Assay Systems, Inc. | 2 | 1992-06-23 |
| Medical Analysis Systems, Inc. | 2 | 1991-10-02 |
27 more applicants have MSJ clearances. See the full list in Caduvo.
Most recent MSJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072977 | General Atomics | DIAZYME APOLIPOPROTEIN A-1 ASSAY | 2008-07-16 | 268 |
| K073488 | Diazyme Laboratories | DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX | 2008-03-07 | 137 |
| K061377 | Pointe Scientific, Inc., | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | 2007-03-28 | 315 |
| K063608 | Dade Behring, Inc. | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | 2007-02-23 | 81 |
| K992662 | Bayer Corp. | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | 2000-02-15 | 190 |
Recalls for MSJ devices
openFDA lists no recalls for product code MSJ.
Frequently asked questions
What is FDA product code MSJ?
MSJ is the FDA product code for apolipoproteins. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is MSJ?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MSJ?
Across 50 cleared submissions the average was 87 days from receipt to decision (median 71).
Which companies have the most MSJ clearances?
Beckman Instruments, Inc. (4); Atlantic Antibodies (4); Instrumentation Laboratory CO (2); Bacton Assay Systems, Inc. (2); Medical Analysis Systems, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MSJ
- Run a recall and safety report across every MSJ manufacturer
- Watch product code MSJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Clinical Chemistry product codes · FDA product code lookup · 510(k) database search · 510(k) review times