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510(k) K112528

ELECSYS T4 CALCHECK 5 by Roche Diagnostics Corporation — Product Code JJX

K112528 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corporation for the device "ELECSYS T4 CALCHECK 5". The FDA issued a decision of Substantially Equivalent on October 18, 2011. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Roche Diagnostics Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2011
Date Received
August 31, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Roche Diagnostics Corporation

  • K141929 — ACCU-CHEK CONNECT DIABETES MANAGEMENT APP (March 16, 2015)
  • K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM (December 17, 2014)
  • K133862 — ACCU-CHEK AVIVA PLUS SYSTEM (April 29, 2014)
  • K070172 — AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (April 17, 2007)
  • K070174 — AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCE (April 16, 2007)

Other clearances for product code JJX

  • K170678 — Beta-CrossLaps CalCheck 5 (April 4, 2017)
  • K162173 — Elecsys CYFRA 21-1 CalCheck 5 (January 12, 2017)
  • K162514 — Multichem A1c (October 26, 2016)
  • K161874 — Audit MicroControls Linearity DROP LQ Blood Glucose (August 10, 2016)
  • K161526 — LIAISON CMV IgM Serum Control Set (June 30, 2016)
  • K161522 — LIAISON EBV IgM Serum Control Set (June 30, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K152117 — Dropper hsCRP High Sensitivity CRP Control (April 21, 2016)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K143687 — ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce (July 17, 2015)

FDA data resources