Cleared Traditional

OSMOCEL 3

K851843 · Hematology Marketing Assoc. · Hematology
Jul 1985
Decision
95d
Days
Class 1
Risk

About This 510(k) Submission

K851843 is an FDA 510(k) clearance for the OSMOCEL 3, a Diluent, Blood Cell (Class I — General Controls, product code GIF), submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on July 30, 1985, 95 days after receiving the submission on April 26, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8200.

Submission Details

510(k) Number K851843 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1985
Decision Date July 30, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIF — Diluent, Blood Cell
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.8200

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