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Device Classification
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CFG — Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Class I
FDA Device Classification
Classification Details
Product Code
CFG
Device Class
Class I
Regulation Number
862.1465
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No
Recent 510(k) Clearances
K-Number
Applicant
Device Name
Date
K860554
sterling diagnostics
SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
March 14, 1986
K800550
dow chemical
LIPASE DETERMINATION
April 2, 1980