510(k) K073488
- Device
- DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K073488
- Product code
- MSJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-07
- Date received
- 2007-10-22
- Regulation
- 862.1475
- Classification name
- Apolipoproteins
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHARLES YU
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers#
- 3005360469
- 9610806
- 2050012
- 3003741796
- 2432235
- 3012963943
- 2250051
- 1319808
- 8040374
- 2182595
- 3003356736
- 3019906
- 3004493545
- 3002642396
- 2050010
- 2032900
- 2085064
- 3023197868
- 3014325803
- 1319681
- 3000308930
Source Documents#
Other 510(k) Records For Product Code MSJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072977 | DIAZYME APOLIPOPROTEIN A-1 ASSAY | General Atomics | 2008-07-16 |
| K061377 | APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS | Pointe Scientific, Inc., | 2007-03-28 |
| K063608 | DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Dade Behring, Inc. | 2007-02-23 |
| K992662 | 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM | Bayer Corp. | 2000-02-15 |
| K970314 | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS | Beckman Instruments, Inc. | 1997-04-21 |
| K964010 | IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT | Beckman Instruments, Inc. | 1997-02-10 |
| K931777 | APO A-1 CHEMILUMINESCENCE ASSAY | Nichols Institute | 1993-08-16 |
| K925702 | NICHOLS APO B CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | 1992-12-23 |
| K923087 | IL TEST APOLIPOPROTEIN A1 | Instrumentation Laboratory CO | 1992-10-26 |
| K923080 | IL TEST APOLIPOROTEIN B (APO B) | Instrumentation Laboratory CO | 1992-10-26 |
| K921795 | BACTON(TM), AUTO-APO A-1 REAGENT | Bacton Assay Systems, Inc. | 1992-06-23 |
| K921862 | BACTON(TM), AUTO-APO B REAGENT | Bacton Assay Systems, Inc. | 1992-06-22 |
| K921037 | APOLIPOPROTEIN TEST SYSTEM | Baxter Diagnostics, Inc. | 1992-05-22 |
| K914069 | REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1 | Medical Analysis Systems, Inc. | 1991-10-02 |
| K912749 | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B | Medical Analysis Systems, Inc. | 1991-09-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary