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510(k) K070848

LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X by Bio-Rad, Diagnostics Grp. — Product Code JJW

K070848 is an FDA 510(k) premarket notification submitted by Bio-Rad, Diagnostics Grp. for the device "LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X". The FDA issued a decision of Substantially Equivalent on April 25, 2007. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Bio-Rad, Diagnostics Grp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2007
Date Received
March 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinalysis Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Bio-Rad, Diagnostics Grp.

  • K121794 — LIQUICHEK URINE CHEMISTRY CONTROL (July 11, 2012)
  • K100727 — LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL (September 14, 2010)
  • K072721 — LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCC (December 11, 2007)
  • K072835 — LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAK (December 11, 2007)
  • K071319 — I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G (June 26, 2007)

Other clearances for product code JJW

  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K142262 — AUTION CHECK PLUS (April 10, 2015)
  • K131444 — UA-CELLULAR COMPLETE (January 29, 2014)
  • K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (September 30, 2011)
  • K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY (February 2, 2011)
  • K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (January 16, 2009)
  • K072640 — IRISPEC,CA/CB/CC (December 21, 2007)
  • K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS (October 3, 2005)
  • K043266 — RANDOX URINE CONTROLS (February 15, 2005)
  • K042446 — QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (November 2, 2004)

FDA data resources