FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SINGLE VIAL LIPASE TEST KIT
K Number: K802842
·
Decision Dec 18, 1980
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
21
Review Days
36
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Basic Information
- Device Name
- SINGLE VIAL LIPASE TEST KIT
- K Number
- K802842
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biodynamics Corp.
- Date Received
- November 12, 1980
- Decision Date
- December 18, 1980
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHI), ordered by most recent decision date.
SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT
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LIPASE-PS ASSAY PROCEDURE NO. 805
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FDA Class 1
·Clinical Chemistry
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