FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CENTRIA INSULIN RIA
K Number: K771979
·
Decision Nov 17, 1977
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
26
Applicant Total
69
Review Days
31
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Basic Information
- Device Name
- CENTRIA INSULIN RIA
- K Number
- K771979
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1405
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Union Carbide Corp.
- Date Received
- October 17, 1977
- Decision Date
- November 17, 1977
- Product Code
- CFP
- 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 |
|---|---|---|---|
| CFP | Radioimmunoassay, Immunoreactive Insulin | FDA class 1 | Clinical Chemistry |
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| K810596 | CENTRIFI CHEM SYSTEM 400 ANALYZER | Mar 17, 1981 | Substantially Equivalent |
| K810129 | CENTRIFICHEM SYSTEM 500 | Feb 2, 1981 | Substantially Equivalent |
| K803216 | CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT | Jan 9, 1981 | Substantially Equivalent |
| K802741 | CENTRIFICHEM COMB. SERUM-BASED CALIB. | Dec 10, 1980 | Substantially Equivalent |
| K802520 | CENTRIFICHEM PIPETTOR ACCURACY CALIB. | Nov 12, 1980 | Substantially Equivalent |