Cleared Traditional

HEMATACHEK

K964452 · Richmond Diagnostics, Inc. · Hematology

Feb 1997

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K964452 is an FDA 510(k) clearance for the HEMATACHEK, a Control, Hematocrit (Class II — Special Controls, product code GLK), submitted by Richmond Diagnostics, Inc. (New Brunswick, US). The FDA issued a Cleared decision on February 20, 1997, 106 days after receiving the submission on November 6, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K964452 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 1996
Decision Date	February 20, 1997
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement