LIPASE DETERMINATION— 510(k) K800550

Substantially Equivalent

The Dow Chemical Co.

FDA 510(k) clearance K800550 for LIPASE DETERMINATION, Substantially Equivalent on 1980-04-02. Applicant: The Dow Chemical Co.. Device class: 1.

Clearance details

Applicant: The Dow Chemical Co.
Product code: Code CFG
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1980-03-10
Decision date: 1980-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CFG

K860554 — SERUM LIPASE REAGENT SET (TURBIDIMETRIC)1986-03-14

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K821536 — DOWFLOW ALT-UV DETERMINATION1982-06-14
K821315 — DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM1982-05-24
K820675 — BILIRUBIN(TOTAL) DETERMINATION CTMS1982-04-01

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