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510(k) K851520

CK/LD ISOENZYMES CONTROLS(HUMAN) by Seragen Diagnostics, Inc. — Product Code JJT

K851520 is an FDA 510(k) premarket notification submitted by Seragen Diagnostics, Inc. for the device "CK/LD ISOENZYMES CONTROLS(HUMAN)". 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. Seragen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1985
Date Received
April 15, 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 Seragen Diagnostics, Inc.

  • K872148 — VIVID CHLAMYDIA(TM) (August 19, 1987)
  • K851663 — QUICK-COUNT HEMATOLOGY CONTROLS (July 23, 1985)
  • K852260 — QUICK-CHEM CALIBRATION SET (July 22, 1985)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K850209 — QUICK-LYTE (February 27, 1985)
  • K844743 — SERATEST ENA(RNP/SM) DETERMINATION (February 4, 1985)
  • K842563 — SERATEST DNA DETERMINATION (October 25, 1984)
  • K841504 — QUICK-COUNT PLUS 2 (June 11, 1984)
  • K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM (April 13, 1984)
  • K840863 — SERATEST RF LATEX DETERMINATION (April 4, 1984)

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