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510(k) K792376

QUANTITATIVE CONTROL URINE II (HUMAN) by Environmental Chemical Specialties — Product Code JJW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 26, 1979
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 Environmental Chemical Specialties

  • K812635 — ANEMIA CONTROL (October 2, 1981)
  • K811810 — URIC ACID TEST (July 15, 1981)
  • K811811 — TDM ANTI-CONVULSANT CONTROL LEVELS I-II (July 10, 1981)
  • K811809 — ANTI-ARRHYTHMIC CONTROL LEVELS I & II (July 10, 1981)
  • K803089 — GAMMA-GLUTAMYL TRANSPEPTIDASE (GGT) (January 2, 1981)
  • K792377 — CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL (September 26, 1980)
  • K801854 — SPINAL FLUID CONTROL(HUMAN) (September 16, 1980)
  • K801061 — TOTAL PROTEIN TEST (July 21, 1980)
  • K792375 — ELEVATED LIPID CONTROL (December 6, 1979)
  • K792374 — QUANTITATIVE CONTROL URINE I (HUMAN) (December 6, 1979)

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)