Cleared Traditional

K840288 - DIACELIN

K840288 is an FDA 510(k) clearance for DIACELIN, manufactured by Diatech, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K840288 · Diatech, Inc. · Hematology device
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Apr 1984
Decision
90d
Days
Class 2
Risk

K840288 is an FDA 510(k) clearance for the DIACELIN. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Diatech, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Diatech, Inc. devices

FDA 510(k) Submission Details - K840288

510(k) Number K840288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1984
Decision Date April 23, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 113d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 92
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K840288.
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · International Technidyne Corp. · Aug 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · International Technidyne Corp. · Aug 1988
VERIFY(R) REFERENCE PLASMA
K881348 · Organon Teknika Corp. · May 1988
CONTACT-K APTT REAGENT
K834086 · Pacific Hemostasis · Feb 1984
CI-TROL COAGULATION CONTROLS II & III
K771346 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977