Cleared Traditional

K930959 - FACTOR CONTROL [P]

K930959 is the FDA 510(k) clearance for FACTOR CONTROL [P] by American Bioproducts Co.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K930959 · American Bioproducts Co. · Hematology device
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May 1993
Decision
85d
Days
Class 2
Risk

K930959 is an FDA 510(k) clearance for the FACTOR CONTROL [P]. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on May 20, 1993 after a review of 85 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 American Bioproducts Co. devices

Submission Details

510(k) Number K930959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date May 20, 1993
Days to Decision 85 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 113d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 29
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K930959.
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
K930267 · Biomerieux Vitek, Inc. · Mar 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401 · Behring Diagnostics, Inc. · Feb 1994
CONTROL PLASMA U
K924402 · Behring Diagnostics, Inc. · Feb 1994
COAG-CONTROL
K930923 · American Bioproducts Co. · Apr 1993
CONTROL PLASMA P
K924405 · Behring Diagnostics, Inc. · Dec 1992
AVK CONTROL I & II
K921665 · American Bioproducts Co. · Jun 1992