ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A— 510(k) K071255

Substantially Equivalent

Hyphen Biomed

FDA 510(k) clearance K071255 for ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A, Substantially Equivalent on 2007-09-07. Applicant: Hyphen Biomed.

Clearance details

Applicant
Hyphen Biomed
Product code
Code LCO
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mason, OH, US
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