510(k) K893894

CHARISE CHARLES REAGENT BLOOD STRIPS by Lee Import Domestic Consulting — Product Code JIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1989
Date Received
May 30, 1989
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