TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1— 510(k) K925203

Name: FDA 510(k) clearance K925203
Creator: U.S. Food and Drug Administration
Published: 1992-11-25

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K925203 for TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1, Substantially Equivalent on 1992-11-25. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1992-08-20
Decision date: 1992-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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