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510(k) K982845

CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3 by More Diagnostics — Product Code JJT

K982845 is an FDA 510(k) premarket notification submitted by More Diagnostics for the device "CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3". The FDA issued a decision of Substantially Equivalent on August 21, 1998. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. More Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1998
Date Received
August 12, 1998
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 More Diagnostics

  • K072257 — MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL (January 30, 2008)
  • K050125 — RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 (March 18, 2005)
  • K980331 — IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE (March 16, 1998)
  • K972976 — CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL (August 29, 1997)
  • K970778 — LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4 (April 17, 1997)
  • K946193 — FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 (August 24, 1995)
  • K943571 — MULTI-LEVEL CONTROL FOR FIBRIN DEGRADATION PRODUCTS (June 15, 1995)
  • K944999 — SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 (June 6, 1995)
  • K941876 — WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 (July 28, 1994)
  • K941698 — SERUM VOLATILES CONTROL - LEVELS 1 AND 2 (July 28, 1994)

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