FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIPASE UV [TOYO]
K Number: K874027
·
Decision May 27, 1988
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
19
Applicant Total
13
Review Days
238
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Basic Information
- Device Name
- LIPASE UV [TOYO]
- K Number
- K874027
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1465
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advocacy International, Ltd.
- Date Received
- October 2, 1987
- Decision Date
- May 27, 1988
- 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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SENTINEL LIPASE LIQUID MODEL 17.401B
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CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS
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IL TEST LIPASE
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LIPASE FLEX REAGENT CARTRIDGE
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LIPASE-PS ASSAY PROCEDURE NO. 805
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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