FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRIA INSULIN RIA
K Number: K791707
·
Decision Oct 17, 1979
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
82
Review Days
50
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Basic Information
- Device Name
- CENTRIA INSULIN RIA
- K Number
- K791707
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Ventrex Laboratories, Inc.
- Date Received
- August 28, 1979
- Decision Date
- October 17, 1979
- Product Code
- CFP
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
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Other Clearances by Ventrex Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |