FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K Number: K880678
·
Decision Apr 5, 1988
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
71
Applicant Total
82
Review Days
46
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
- MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
- K Number
- K880678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ventrex Laboratories, Inc.
- Date Received
- February 19, 1988
- Decision Date
- April 5, 1988
- Product Code
- DHA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| DHA | System, Test, Human Chorionic Gonadotropin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DHA), ordered by most recent decision date.
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
FDA 510(k)
FDA Class 2
·Clinical Chemistry
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Access Total ßhCG (5th IS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer
FDA 510(k)
FDA Class 2
·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 |