FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHNICON IMMUNO 1 SYSTEM
K Number: K962125
·
Decision Aug 2, 1996
Classifications
1
FEI Numbers
174
Registration Numbers
174
Same Product Code
207
Applicant Total
96
Review Days
60
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Basic Information
- Device Name
- TECHNICON IMMUNO 1 SYSTEM
- K Number
- K962125
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- June 3, 1996
- Decision Date
- August 2, 1996
- Product Code
- JJE
- 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 |
|---|---|---|---|
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | FDA class 1 | Clinical Chemistry |
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