FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMVARION(TM)
K Number: K862586
·
Decision Aug 4, 1986
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- CHEMVARION(TM)
- K Number
- K862586
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- G.B.F. Industries, Inc.
- Date Received
- July 7, 1986
- Decision Date
- August 4, 1986
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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