510(k) K921495

DIA STRIPS SYSTEM, MODIFIED by Symcon Intl., Inc. — Product Code JIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1992
Date Received
March 6, 1992
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