Cleared Traditional

WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY

K880544 · Wescor, Inc. · Hematology

Apr 1988

Decision

52d

Days

Class 1

Risk

About This 510(k) Submission

K880544 is an FDA 510(k) clearance for the WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY, a Romanowsky Stains (Class I — General Controls, product code GJL), submitted by Wescor, Inc. (Logan, US). The FDA issued a Cleared decision on April 1, 1988, 52 days after receiving the submission on February 9, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.1850.

Submission Details

510(k) Number	K880544 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 1988
Decision Date	April 01, 1988
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—