Cleared Traditional

K905203 - COAGULATION REFERENCE PLASMA

K905203 is the FDA 510(k) clearance for COAGULATION REFERENCE PLASMA by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code GIZ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K905203 · Medical Diagnostic Technologies, Inc. · Hematology device
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Dec 1990
Decision
38d
Days
Class 2
Risk

K905203 is an FDA 510(k) clearance for the COAGULATION REFERENCE PLASMA, NORMAL. Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 38 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 Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K905203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1990
Decision Date December 28, 1990
Days to Decision 38 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
75d faster than avg
Panel avg: 113d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIZ Plasma, Control, Normal
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 - GIZ Plasma, Control, Normal

All 13
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K905203.
CONTROL PLASMA N
K924403 · Behring Diagnostics, Inc. · Feb 1994
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · American Diagnostic Corp. · Oct 1993
UNICALIBRATOR KIT
K922021 · American Bioproducts Co. · Jun 1992
NORMAL COAGULATION CONTROL PLASMA (NCCP)
K895262 · Medical Diagnostic Technologies, Inc. · Oct 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
K893783 · Analytical Control Systems, Inc. · Jun 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
K893784 · Analytical Control Systems, Inc. · Jun 1989