FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIRON(TM)
K Number: K872646
·
Decision Sep 14, 1987
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
96
Applicant Total
251
Review Days
70
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Basic Information
- Device Name
- VIRON(TM)
- K Number
- K872646
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- bioMerieux, Inc.
- Date Received
- July 6, 1987
- Decision Date
- September 14, 1987
- Product Code
- JJT
- 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 |
|---|---|---|---|
| JJT | Enzyme Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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