Cleared Traditional

DADE INNOVIN II

K935702 · Baxter Diagnostics, Inc. · Hematology
Nov 1994
Decision
357d
Days
Class 2
Risk

About This 510(k) Submission

K935702 is an FDA 510(k) clearance for the DADE INNOVIN II, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Baxter Diagnostics, Inc. (Mcgaw Park, US). The FDA issued a Cleared decision on November 22, 1994, 357 days after receiving the submission on November 30, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K935702 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1993
Decision Date November 22, 1994
Days to Decision 357 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750