Cleared Traditional

LASER-GLOBIN

K850096 · Hematology Marketing Assoc. · Hematology
Mar 1985
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K850096 is an FDA 510(k) clearance for the LASER-GLOBIN, 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 K850096 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 —

Device Classification

Product Code GKR — System, Hemoglobin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5620