FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIPASE REAGENT SET
K Number: K790796
·
Decision Jul 17, 1979
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
14
Applicant Total
5
Review Days
84
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Basic Information
- Device Name
- LIPASE REAGENT SET
- K Number
- K790796
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Alta Diagnostics, Inc.
- Date Received
- April 24, 1979
- Decision Date
- July 17, 1979
- Product Code
- CET
- 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 |
|---|---|---|---|
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | FDA class 1 | Clinical Chemistry |
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