Cleared Traditional

K895504 - ABNORMAL REFERENCE PLASMA-IX

K895504 is the FDA 510(k) clearance for ABNORMAL REFERENCE PLASMA-IX by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code GJT) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K895504 · Medical Diagnostic Technologies, Inc. · Hematology device
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Oct 1989
Decision
24d
Days
Class 2
Risk

K895504 is an FDA 510(k) clearance for the ABNORMAL REFERENCE PLASMA-IX. Classified as Plasma, Coagulation Factor Deficient (product code GJT), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 K895504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date October 06, 1989
Days to Decision 24 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
89d faster than avg
Panel avg: 113d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 62
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K895504.
FACTOR II DEFICIENT PLASMA
K900906 · Sigma Chemical Co. · Mar 1990
FACTOR II DEFICIENT PLASMA
K900133 · Medical Diagnostic Technologies, Inc. · Jan 1990
ABNORMAL REFERENCE PLASMA-VIII
K895503 · Medical Diagnostic Technologies, Inc. · Oct 1989
FACTOR X DEFICIENT PLASMA
K893523 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR IX DEFICIENT PLASMA
K893524 · Medical Diagnostic Technologies, Inc. · Jun 1989
FACTOR VIII DEFICIENT PLASMA
K893525 · Medical Diagnostic Technologies, Inc. · Jun 1989