FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASSURE LEVEL II PROD. #30172
K Number: K801539
·
Decision Sep 9, 1980
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
50
Review Days
68
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Basic Information
- Device Name
- ASSURE LEVEL II PROD. #30172
- K Number
- K801539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- July 3, 1980
- Decision Date
- September 9, 1980
- 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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