Home / 510(k) Clearances / K974343

510(k) K974343

DADE INNOVIN by Dade Intl., Inc. — Product Code GJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1998
Date Received
November 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Prothrombin
Device Class
Class II
Regulation Number
864.7750
Review Panel
HE
Submission Type

Other clearances by Dade Intl., Inc.

  • K970505 — DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/ (November 17, 1997)
  • K973974 — DADE TRU-LIQUID CARDIAC CONTROL (November 6, 1997)
  • K973668 — CARDIAC TROPONIN-I (TROP) CALIBRATOR (October 20, 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)

Other clearances for product code GJS

  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K251564 — microINR System (July 21, 2025)
  • K243543 — microINR System (February 27, 2025)
  • K230802 — Xprecia Prime Coagulation System (March 15, 2024)
  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K231711 — microINR System (July 11, 2023)
  • K211485 — STA- NeoPTimal (December 23, 2022)
  • K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (October 5, 2022)
  • K213426 — HemosIL ReadiPlasTin (August 16, 2022)
  • K201185 — microINR System (December 18, 2020)