Cleared Traditional

K943225 - COAMATIC FACTOR VIII

K943225 is an FDA 510(k) clearance for COAMATIC FACTOR VIII, manufactured by Pharmacia Hepar, Inc.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 488-day FDA review.

K943225 · Pharmacia Hepar, Inc. · Hematology device
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Nov 1995
Decision
488d
Days
Class 2
Risk

K943225 is an FDA 510(k) clearance for the COAMATIC FACTOR VIII. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Pharmacia Hepar, Inc. (Franklin, US). The FDA issued a Cleared decision on November 6, 1995 after a review of 488 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Pharmacia Hepar, Inc. devices

FDA 510(k) Submission Details - K943225

510(k) Number K943225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date November 06, 1995
Days to Decision 488 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
375d slower than avg
Panel avg: 113d · This submission: 488d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 158
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K943225.
CHROM Z-PLASMINOGEN, CAT. NO. 5244
K952669 · Helena Laboratories · Dec 1995
ASSERACHROM FREE PROTEIN S KIT
K954017 · American Bioproducts Co. · Nov 1995
ASSERACHROM TOTAL PROTEIN S KIT
K954040 · American Bioproducts Co. · Nov 1995
PROTEIN C REAGENT, COAGULOMETRIC
K924425 · Behring Diagnostics, Inc. · Jan 1995
RISTOCETIN COFACTOR ASSAY KIT
K945414 · Chrono-Log Corp. · Jan 1995
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
K934210 · Biomerieux Vitek, Inc. · Dec 1994