Cleared Traditional

K934351 - APTT-ES REAGENT

K934351 is an FDA 510(k) clearance for APTT-ES REAGENT, manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K934351 · Medical Diagnostic Technologies, Inc. · Hematology device
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Dec 1993
Decision
90d
Days
Class 2
Risk

K934351 is an FDA 510(k) clearance for the APTT-ES REAGENT. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on December 6, 1993 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 864.7925 - 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 Medical Diagnostic Technologies, Inc. devices

FDA 510(k) Submission Details - K934351

510(k) Number K934351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date December 06, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
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.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 43
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K934351.
PATHROMTIN SL
K955450 · Behring Diagnostics, Inc. · Apr 1996
SYNTHASIL APTT REAGENT
K953981 · Ortho Diagnostic Systems, Inc. · Nov 1995
APTT-ES
K935169 · Helena Laboratories · Dec 1994
PATHROMTIN
K932011 · Behring Diagnostics, Inc. · Oct 1993
ACS APCT REAGENT, MODIFIED
K926012 · Analytical Control Systems, Inc. · Apr 1993
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
K924637 · International Technidyne Corp. · Jan 1993