FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHNICON SMA & AAII SYSTEMS
K Number: K770406
·
Decision Jun 2, 1977
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
38
Review Days
91
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Basic Information
- Device Name
- TECHNICON SMA & AAII SYSTEMS
- K Number
- K770406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Laboratories
- Date Received
- March 3, 1977
- Decision Date
- June 2, 1977
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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