LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT— 510(k) K897150

Name: FDA 510(k) clearance K897150
Creator: U.S. Food and Drug Administration
Published: 1990-02-26

Substantially Equivalent

Toyo Jozo Co., Ltd.

FDA 510(k) clearance K897150 for LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT, Substantially Equivalent on 1990-02-26. Applicant: Toyo Jozo Co., Ltd.. Device class: 1.

Clearance details

Applicant: Toyo Jozo Co., Ltd.
Product code: Code CHI
Device class: Class 1
Regulation: 21 CFR 862.1465
Advisory panel: Clinical Chemistry
Date received: 1989-12-26
Decision date: 1990-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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