Cleared Traditional

K891169 - DADE THROMBOPLASTIN IS (FDA 510(k) Clearance)

K891169 · Baxter Healthcare Corp · Hematology device

Apr 1989

Decision

35d

Days

Class 2

Risk

K891169 is an FDA 510(k) clearance for the DADE THROMBOPLASTIN IS. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on April 10, 1989, 35 days after receiving the submission on March 6, 1989.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number	K891169 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 06, 1989
Decision Date	April 10, 1989
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—