Cleared Traditional

K904073 - COAGULATION REFERENCE PLASMA, ABNORMAL

K904073 is an FDA 510(k) clearance for COAGULATION REFERENCE PLASMA, manufactured by Medi-Tech, Inc.. The device is a Class 2 Hematology device with product code GGC cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K904073 · Medi-Tech, Inc. · Hematology device
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Oct 1990
Decision
47d
Days
Class 2
Risk

K904073 is an FDA 510(k) clearance for the COAGULATION REFERENCE PLASMA, ABNORMAL. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Ventura, US). The FDA issued a Cleared decision on October 22, 1990 after a review of 47 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 Medi-Tech, Inc. devices

FDA 510(k) Submission Details - K904073

510(k) Number K904073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date October 22, 1990
Days to Decision 47 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
66d faster than avg
Panel avg: 113d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGC Device Classification - Class 2, Special Controls

Product Code GGC Control, Plasma, Abnormal
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 - GGC Control, Plasma, Abnormal

All 35
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K904073.
CONTROL PLASMA P
K924405 · Behring Diagnostics, Inc. · Dec 1992
AVK CONTROL I & II
K921665 · American Bioproducts Co. · Jun 1992
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · Baxter Healthcare Corp · Jun 1991
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233 · Ortho Diagnostic Systems, Inc. · Apr 1990
HEPARIN CONTROL PLASMA, FOR USE IN APTT
K900782 · Medical Diagnostic Technologies, Inc. · Mar 1990
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
K895260 · Medical Diagnostic Technologies, Inc. · Oct 1989