CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM— 510(k) K950186

Name: FDA 510(k) clearance K950186
Creator: U.S. Food and Drug Administration
Published: 1995-03-13

Substantially Equivalent

Miles, Inc.

FDA 510(k) clearance K950186 for CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM, Substantially Equivalent on 1995-03-13. Applicant: Miles, Inc.. Device class: 2.

Clearance details

Applicant: Miles, Inc.
Product code: Code JHW
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1995-01-17
Decision date: 1995-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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