TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)— 510(k) K930685

Name: FDA 510(k) clearance K930685
Creator: U.S. Food and Drug Administration
Published: 1993-06-22

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K930685 for TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.), Substantially Equivalent on 1993-06-22. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1993-02-10
Decision date: 1993-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

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