Home / 510(k) Clearances / K993715

510(k) K993715

QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3 by Seracare Technology — Product Code JJT

K993715 is an FDA 510(k) premarket notification submitted by Seracare Technology for the device "QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3". The FDA issued a decision of Substantially Equivalent on November 16, 1999. The device falls under product code JJT (Enzyme Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Seracare Technology has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1999
Date Received
November 3, 1999
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 Seracare Technology

  • K993631 — QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2 (December 9, 1999)
  • K992939 — QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3 (December 9, 1999)
  • K992770 — QUALITROL IMMUNOLOGY CONTROL, LEVEL 1, 2 AND 3 (November 12, 1999)
  • K992395 — URINE DRUG SCREENING CONTROL (August 26, 1999)

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)
  • K992430 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (August 30, 1999)
  • K984437 — QUANTEX ASO-CRP-RP CONTROL II (February 2, 1999)
  • K984277 — CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3 (December 9, 1998)

FDA data resources