Cleared Traditional

K851843 - OSMOCEL 3

K851843 is the FDA 510(k) clearance for OSMOCEL 3 by Hematology Marketing Assoc.. It is a Class 1 Hematology device (product code GIF) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851843 · Hematology Marketing Assoc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
95d
Days
Class 1
Risk

K851843 is an FDA 510(k) clearance for the OSMOCEL 3. Classified as Diluent, Blood Cell (product code GIF), Class I - General Controls.

Submitted by Hematology Marketing Assoc. (Concord, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8200 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hematology Marketing Assoc. devices

Submission Details

510(k) Number K851843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1985
Decision Date July 30, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 113d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIF Diluent, Blood Cell
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GIF Diluent, Blood Cell

All 12
Devices cleared under the same product code (GIF) and FDA review panel - the closest regulatory comparables to K851843.
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
K882490 · R&D Systems, Inc. · Jul 1988
SYSMEX QUICKLYSER-II (QLS-200A)
K882267 · Toa Medical Electronics USA, Inc. · Jul 1988
SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
K850239 · Toa Medical Electronics USA, Inc. · Apr 1985
HAYEM DILUTING FLUID
K842929 · E K Ind., Inc. · Sep 1984
UNITIZED HEMATOLOGY SET 65132/93
K840477 · Emd Chemicals, Inc. · Mar 1984
REAGENT FOR COULTER COUNTER MODEL 5+11
K821683 · Fisher Scientific Co., LLC · Jun 1982