Cleared Traditional

K931118 - ASSESS(TM) HIGH ABNORMAL CONTROL (FDA 510(k) Clearance)

K931118 · Instrumentation Laboratory CO · Hematology device

Mar 1994

Decision

391d

Days

Class 2

Risk

K931118 is an FDA 510(k) clearance for the ASSESS(TM) HIGH ABNORMAL CONTROL. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 30, 1994, 391 days after receiving the submission on March 4, 1993.

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

Submission Details

510(k) Number	K931118 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 04, 1993
Decision Date	March 30, 1994
Days to Decision	391 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF