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510(k) K111999

HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL by Healgen Scientific,, LLC — Product Code JIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2012
Date Received
July 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood, Occult, Colorimetric, In Urine
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

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