FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
K Number: K850999
·
Decision Apr 8, 1985
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
157
Review Days
28
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Basic Information
- Device Name
- TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN
- K Number
- K850999
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Technicon Instruments Corp.
- Date Received
- March 11, 1985
- Decision Date
- April 8, 1985
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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