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510(k) K894554

CLP CK/LD ISOENZYME CONTROL by Creative Laboratory Products, Inc. — Product Code JJT

K894554 is an FDA 510(k) premarket notification submitted by Creative Laboratory Products, Inc. for the device "CLP CK/LD ISOENZYME CONTROL". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Creative Laboratory Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
July 20, 1989
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 Creative Laboratory Products, Inc.

  • K950589 — CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (March 20, 1995)
  • K942284 — CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (August 26, 1994)
  • K922995 — LIPID CONTROLS (August 12, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K913371 — TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (November 8, 1991)
  • K913585 — LIPASE LINEARITY CONTROL (October 21, 1991)
  • K913224 — LIPID LINEARITY CONTROLS (September 25, 1991)
  • K913496 — CHOLINESTERASE LINEARITY CONTROL (September 11, 1991)
  • K912823 — HIGH DENSITY LIPOPROTEIN CHOLESTEROL (August 16, 1991)
  • K912725 — TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (July 30, 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