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510(k) K951877

AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE by Chimera Research & Chemical, Inc. — Product Code KQO

K951877 is an FDA 510(k) premarket notification submitted by Chimera Research & Chemical, Inc. for the device "AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE". The FDA issued a decision of Substantially Equivalent on May 14, 1996. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Chimera Research & Chemical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1996
Date Received
April 7, 1995
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

Other clearances by Chimera Research & Chemical, Inc.

  • K970087 — CR PERFECT (March 6, 1997)
  • K953393 — TOX PERFECT A TUBE (October 6, 1995)
  • K952501 — TOX PERFECT B TUBES AND REAGENTS (August 24, 1995)
  • K950142 — CR PERFECT (May 25, 1995)
  • K940768 — AD PERFECT (February 17, 1995)
  • K935408 — UA PERFECT (June 13, 1994)

Other clearances for product code KQO

  • K141874 — URISCAN OPTIMA (May 28, 2015)
  • K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid (May 11, 2015)
  • K140717 — CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALI (November 17, 2014)
  • 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