Cleared Traditional

EZCHEK/HBA BLOOD COLLECTION KIT

K971919 · Flexsite Diagnostics, Inc. · Hematology

Sep 1997

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K971919 is an FDA 510(k) clearance for the EZCHEK/HBA BLOOD COLLECTION KIT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Flexsite Diagnostics, Inc. (Washington, US). The FDA issued a Cleared decision on September 5, 1997, 105 days after receiving the submission on May 23, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number	K971919 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1997
Decision Date	September 05, 1997
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF