Cleared Traditional

LASER-GLOBIN POWDER

K850094 · Hematology Marketing Assoc. · Hematology

Mar 1985

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K850094 is an FDA 510(k) clearance for the LASER-GLOBIN POWDER, a System, Hemoglobin, Automated (Class II — Special Controls, product code GKR), submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on March 29, 1985, 77 days after receiving the submission on January 11, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5620.

Submission Details

510(k) Number	K850094 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1985
Decision Date	March 29, 1985
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—