Cleared Traditional

DRABKIN REAGENT

K842931 · E K Ind., Inc. · Hematology

Sep 1984

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K842931 is an FDA 510(k) clearance for the DRABKIN REAGENT, a Holder, Speculum, Ent (Class I — General Controls, product code KAG), submitted by E K Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1984, 58 days after receiving the submission on July 25, 1984. This device falls under the Hematology review panel. Regulated under 21 CFR 878.1800.

Submission Details

510(k) Number	K842931 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 1984
Decision Date	September 21, 1984
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—