HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II— 510(k) K882480

Substantially Equivalent

International Technidyne Corp.

FDA 510(k) clearance K882480 for HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II, Substantially Equivalent on 1988-08-30. Applicant: International Technidyne Corp.. Device class: 2.

Clearance details

Applicant
International Technidyne Corp.
Product code
Code GGN
Device class
Class 2
Regulation
21 CFR 864.5425
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Edison, NJ, US
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