DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET— 510(k) K884197

Name: FDA 510(k) clearance K884197
Creator: U.S. Food and Drug Administration
Published: 1988-12-14

Substantially Equivalent

Casco Standards

FDA 510(k) clearance K884197 for DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET, Substantially Equivalent on 1988-12-14. Applicant: Casco Standards. Device class: 2.

Clearance details

Applicant: Casco Standards
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1988-10-06
Decision date: 1988-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yarmouth, ME, US

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