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510(k) K935702

DADE INNOVIN II by Baxter Diagnostics, Inc. — Product Code GJS

K935702 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "DADE INNOVIN II". The FDA issued a decision of Substantially Equivalent on November 22, 1994. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Baxter Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1994
Date Received
November 30, 1993
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 Baxter Diagnostics, Inc.

  • K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (July 18, 1995)
  • K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI (April 25, 1995)
  • K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS (April 14, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)
  • K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (March 7, 1995)
  • K941030 — DRIED GRAM-NEGATIVE CEFPODOXIME (February 16, 1995)
  • K940917 — LORACARBEF GRAM-NAGATIVE PANELS (February 8, 1995)
  • K941459 — GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX (February 3, 1995)
  • K941317 — DRIED GRAM NEGATIVE/CEFMETAZOLE (January 31, 1995)
  • K942089 — MICRODILUTION/LORACARBEF PANELS (January 9, 1995)

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)

FDA data resources