Home / 510(k) Clearances / K840618

510(k) K840618

LIQUI-URA CHEMISTRY URINE CONTROLS by Biodiagnostic Intl — Product Code JJW

K840618 is an FDA 510(k) premarket notification submitted by Biodiagnostic Intl for the device "LIQUI-URA CHEMISTRY URINE CONTROLS". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Biodiagnostic Intl has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
February 14, 1984
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 Biodiagnostic Intl

  • K031296 — LIQUI-HEME GLYCO A1C ASSAY (October 15, 2004)
  • K881430 — LIQUI-SERA SERUM ALCOHOL CONTROLS (July 8, 1988)
  • K874459 — LIQUI-SERA SPINAL FLUID CONTROL (December 29, 1987)
  • K863849 — LIQUI-SERA COMBO LIGAND/TDM CONTROLS (November 24, 1986)
  • K853906 — LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (October 4, 1985)
  • K853887 — LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (September 30, 1985)
  • K842668 — LIQUI-HEME HEMOGLOBIN CALIBRATORS (March 5, 1985)
  • K834398 — LIQUI-SERA TDM CALIBRATORS (February 3, 1984)
  • K834259 — LIQUI-URA TOXIC URINE CONTROL (January 30, 1984)
  • K831278 — LIQUI-SERA ANTICONVULSANTS CONTROLS (May 27, 1983)

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)
  • K070848 — LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,43 (April 25, 2007)
  • K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS (October 3, 2005)
  • K043266 — RANDOX URINE CONTROLS (February 15, 2005)

FDA data resources