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510(k) K973668

CARDIAC TROPONIN-I (TROP) CALIBRATOR by Dade Intl., Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1997
Date Received
September 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Dade Intl., Inc.

  • K974343 — DADE INNOVIN (July 22, 1998)
  • K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/ (November 17, 1997)
  • K973974 — DADE TRU-LIQUID CARDIAC CONTROL (November 6, 1997)
  • K972524 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (September 8, 1997)
  • K972782 — DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (August 15, 1997)
  • K972287 — DADE TRU-LIQUID BILIRUBIN CONTROL (July 7, 1997)
  • K964660 — PARAMAX CHOLESTEROL REAGENT (June 4, 1997)
  • K970676 — DRIED GRAM-NEGATIVE MIC/COMBO PANELS (May 2, 1997)
  • K964715 — PARAMAX SALICYLATE REAGENT (April 25, 1997)
  • K970330 — DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE (April 14, 1997)

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