ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR— 510(k) K930477

Name: FDA 510(k) clearance K930477
Creator: U.S. Food and Drug Administration
Published: 1993-06-07

Substantially Equivalent

Analytical Control Systems, Inc.

FDA 510(k) clearance K930477 for ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR, Substantially Equivalent on 1993-06-07. Applicant: Analytical Control Systems, Inc.. Device class: 2.

Clearance details

Applicant: Analytical Control Systems, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1993-01-29
Decision date: 1993-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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