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510(k) K980047

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

K980047 is an FDA 510(k) premarket notification submitted by Yeongdong Pharmaceutical Corp. for the device "URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on June 10, 1998. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900.

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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  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)
  • K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (March 23, 2011)
  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K093555 — COBAS U411 TEST SYSTEM (April 2, 2010)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K070929 — ACON U120 URINE ANALYZER, MODEL U111-101 (July 30, 2007)

FDA data resources