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510(k) K850907

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ by Cala Diagnostics — Product Code JJT

K850907 is an FDA 510(k) premarket notification submitted by Cala Diagnostics for the device "CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code JJT (Enzyme 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
June 25, 1985
Date Received
March 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme 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)
  • K930873 — CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (April 13, 1993)
  • K930875 — CKMB CONTROL - LEVEL 1,2,3 (April 13, 1993)
  • K926015 — CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 (December 28, 1992)
  • 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)

Other clearances for product code JJT

  • K090940 — SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (December 14, 2009)
  • K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER (October 3, 2006)
  • K030768 — CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL (March 21, 2003)
  • K030102 — ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 (January 24, 2003)
  • K021498 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL (May 24, 2002)
  • K012656 — LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (September 6, 2001)
  • K993723 — CARDIASURE CARDIAC MARKERS CONTROL (November 23, 1999)
  • K993715 — QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 (November 16, 1999)
  • K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (August 30, 1999)
  • K984437 — QUANTEX ASO-CRP-RP CONTROL II (February 2, 1999)

FDA data resources