Cleared Traditional

REES & ECKER DILUTION FLUID

K842921 · E K Ind., Inc. · Hematology

Sep 1984

Decision

44d

Days

Class 1

Risk

About This 510(k) Submission

K842921 is an FDA 510(k) clearance for the REES & ECKER DILUTION FLUID, a Platelet Counting, Manual (Class I — General Controls, product code GLG), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984, 44 days after receiving the submission on July 25, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6160.

Submission Details

510(k) Number	K842921 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1984
Decision Date	September 07, 1984
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—