FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENESYS GAMMA COUNTER
K Number: K851689
·
Decision Aug 7, 1985
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
4
Review Days
103
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Basic Information
- Device Name
- GENESYS GAMMA COUNTER
- K Number
- K851689
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Laboratory Technologies, Inc.
- Date Received
- April 26, 1985
- Decision Date
- August 7, 1985
- Product Code
- JJJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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