FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHNICON RA 1000 SYSTEM
K Number: K813077
·
Decision Nov 16, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
31
Applicant Total
2
Review Days
14
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Basic Information
- Device Name
- TECHNICON RA 1000 SYSTEM
- K Number
- K813077
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technicon Corp.
- Date Received
- November 2, 1981
- Decision Date
- November 16, 1981
- Product Code
- JJC
- 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 |
|---|---|---|---|
| JJC | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Technicon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K791323 | TECHNION ELECTRONIC FEVER THERMOMETER | Sep 7, 1979 | Substantially Equivalent |