FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENTREX APO B
K Number: K861919
·
Decision Jun 6, 1986
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
82
Review Days
18
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Basic Information
- Device Name
- VENTREX APO B
- K Number
- K861919
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ventrex Laboratories, Inc.
- Date Received
- May 19, 1986
- Decision Date
- June 6, 1986
- 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
Other Clearances by Ventrex Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914554 | SPECIFIC IGE EIA-TURBO ASSAY | Mar 13, 1992 | Substantially Equivalent |
| K913833 | VENTREX ALLERGEN DISC | Feb 21, 1992 | Substantially Equivalent |
| K913434 | VENTREX COATED TUBE INTACT PTH | Oct 25, 1991 | Substantially Equivalent |
| K905612 | VENTREX COATED TUBE IGE RADIOIMMUNOASSAY | Feb 21, 1991 | Substantially Equivalent |
| K905636 | VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY | Feb 7, 1991 | Substantially Equivalent |
| K905247 | SHBG IRMA KIT | Jan 17, 1991 | Substantially Equivalent |
| K904330 | TURBO-RAST SPECIFIC IGE ASSAY | Dec 7, 1990 | Substantially Equivalent |
| K903000 | TURBO-RAST SPECIFIC IGE ASSAY | Jul 31, 1990 | Substantially Equivalent |
| K897083 | VENTRESIGN STREP A TEST | Jan 22, 1990 | Substantially Equivalent |
| K895648 | COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. | Jan 18, 1990 | Substantially Equivalent |