FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZYMATIC LIPASE MAX-PACK REAGENT
K Number: K760786
·
Decision Jan 6, 1977
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
3
Review Days
92
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Basic Information
- Device Name
- ENZYMATIC LIPASE MAX-PACK REAGENT
- K Number
- K760786
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem
- Date Received
- October 6, 1976
- Decision Date
- January 6, 1977
- Product Code
- CHI
- 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 |
|---|---|---|---|
| CHI | Lipase-Esterase, Enzymatic, Photometric, Lipase | FDA class 1 | Clinical Chemistry |
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