Cleared Traditional

K882480 - HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II

K882480 is an FDA 510(k) clearance for HEMOCHRON CONTROL PLASMA NORMAL/ABNORMA..., manufactured by International Technidyne Corp.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K882480 · International Technidyne Corp. · Hematology device
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Aug 1988
Decision
75d
Days
Class 2
Risk

K882480 is an FDA 510(k) clearance for the HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 75 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all International Technidyne Corp. devices

FDA 510(k) Submission Details - K882480

510(k) Number K882480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1988
Decision Date August 30, 1988
Days to Decision 75 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
38d faster than avg
Panel avg: 113d · This submission: 75d
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 72
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K882480.
ROCKET REFERENCE PLASMA, CAT NO. 5188
K900019 · Helena Laboratories · Jan 1990
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · Baxter Healthcare Corp · Feb 1989
COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)
K884854 · Precision Biologicals, Inc. · Jan 1989
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
DIACELIN
K840288 · Diatech, Inc. · Apr 1984