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510(k) K861756

V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II by Texas Immunology, Inc. — Product Code JJW

K861756 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II". The FDA issued a decision of Substantially Equivalent on Jul 7, 1986. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 7, 1986
Date Received
May 6, 1986
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 Texas Immunology, Inc.

  • K991465 — DRUG STOP (Dec 10, 1999)
  • K980153 — DRUG CHECK (Mar 27, 1998)
  • K973208 — FIRST SIGN (Oct 20, 1997)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (Jul 23, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (Feb 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (Jul 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (Oct 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (Apr 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (Feb 17, 1989)

Other clearances for product code JJW

  • K170091 — UA-Cellular Complete (Feb 9, 2017)
  • K142262 — AUTION CHECK PLUS (Apr 10, 2015)
  • K131444 — UA-CELLULAR COMPLETE (Jan 29, 2014)
  • K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (Sep 30, 2011)
  • K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY (Feb 2, 2011)
  • K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (Jan 16, 2009)
  • K072640 — IRISPEC,CA/CB/CC (Dec 21, 2007)
  • K070848 — LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,43 (Apr 25, 2007)
  • K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS (Oct 3, 2005)
  • K043266 — RANDOX URINE CONTROLS (Feb 15, 2005)

FDA data resources