FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APO B RIA KIT
K Number: K851389
·
Decision Jul 10, 1985
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
3
Review Days
92
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- APO B RIA KIT
- K Number
- K851389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Iso-Tex Diagnostics
- Date Received
- April 9, 1985
- Decision Date
- July 10, 1985
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
DIAZYME APOLIPOPROTEIN A-1 ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
FDA 510(k)
FDA Class 1
·Clinical Chemistry
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry