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510(k) K980047

URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER by Yeongdong Pharmaceutical Corp. — Product Code KQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1998
Date Received
January 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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