ABC CALIBRATION VERIFIERS— 510(k) K973791

Name: FDA 510(k) clearance K973791
Creator: U.S. Food and Drug Administration
Published: 1997-10-14

Substantially Equivalent

Sc Calibrators & Controls, LLC

FDA 510(k) clearance K973791 for ABC CALIBRATION VERIFIERS, Substantially Equivalent on 1997-10-14. Applicant: Sc Calibrators & Controls, LLC. Device class: 1.

Clearance details

Applicant: Sc Calibrators & Controls, LLC
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1997-10-06
Decision date: 1997-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Monica, CA, US

Download summary PDF View on FDA.gov ↗

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