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510(k) K926015

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 by Cala Diagnostics — Product Code JJX

K926015 is an FDA 510(k) premarket notification submitted by Cala Diagnostics for the device "CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3". The FDA issued a decision of Substantially Equivalent on December 28, 1992. The device falls under product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Cala Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1992
Date Received
November 30, 1992
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 Cala Diagnostics

  • K944246 — CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (October 31, 1994)
  • K944247 — CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL (October 31, 1994)
  • K944243 — CARDIOCHEX (October 27, 1994)
  • K930874 — LD-1 CONTROL-LEVEL 1 & 2 (April 22, 1993)
  • K930875 — CKMB CONTROL - LEVEL 1,2,3 (April 13, 1993)
  • K930873 — CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (April 13, 1993)
  • K915503 — FIBRINOGEN FDP CONTROL (January 30, 1992)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)
  • K864456 — CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 (May 6, 1987)

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