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510(k) K170091

UA-Cellular Complete by Streck — Product Code JJW

K170091 is an FDA 510(k) premarket notification submitted by Streck for the device "UA-Cellular Complete". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Streck has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2017
Date Received
January 10, 2017
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 Streck

  • K260041 — MDx-Chex for BCP (March 27, 2026)
  • K254166 — MDx-Chex for BCN (March 23, 2026)
  • K254167 — MDx-Chex for BCY (March 17, 2026)
  • K231776 — Cell-Free DNA BCT (July 26, 2024)
  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K231221 — MDx-Chex for BC-GP (July 27, 2023)
  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • DEN200001 — Cell-Free DNA BCT (August 7, 2020)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160585 — XN CAL (December 22, 2016)

Other clearances for product code JJW

  • 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)
  • K042446 — QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS (November 2, 2004)

FDA data resources