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510(k) K946145

CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL by Clinical Controls, Inc. — Product Code JJT

K946145 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL". The FDA issued a decision of Substantially Equivalent on January 24, 1995. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Clinical Controls, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1995
Date Received
December 16, 1994
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 Clinical Controls, Inc.

  • K012907 — LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL (September 28, 2001)
  • K964278 — WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTRO (November 22, 1996)
  • K962432 — LIQUISPEX URINE (MICRO)ALBUMIN CONTROL (July 5, 1996)
  • K955690 — AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3 (April 24, 1996)
  • K955691 — SERUM VOLATILES CONTROL LEVEL 1 & 2 (April 24, 1996)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K946050 — LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946048 — LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2 (February 10, 1995)
  • K946266 — FERRITIN CONTROL - LEVEL 1, 2, 3 (February 10, 1995)

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