Cleared Traditional

K884854 - COAGULATION CONTROL PLASMA (NORMAL & AB...

K884854 is the FDA 510(k) clearance for COAGULATION CONTROL PLASMA (NORMAL & AB... by Precision Biologicals, Inc.. It is a Class 2 Hematology device (product code GGN) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K884854 · Precision Biologicals, Inc. · Hematology device
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Jan 1989
Decision
73d
Days
Class 2
Risk

K884854 is an FDA 510(k) clearance for the COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL). Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, CA). The FDA issued a Cleared decision on January 30, 1989 after a review of 73 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 Precision Biologicals, Inc. devices

Submission Details

510(k) Number K884854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1988
Decision Date January 30, 1989
Days to Decision 73 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 113d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGN Plasma, Coagulation Control
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 - GGN Plasma, Coagulation Control

All 56
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K884854.
ORTHOKROME NORMAL AND ABNORMAL CONTROL PLASMA
K902210 · Ortho Diagnostic Systems, Inc. · Jul 1990
ROCKET REFERENCE PLASMA, CAT NO. 5188
K900019 · Helena Laboratories · Jan 1990
DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO
K884901 · Baxter Healthcare Corp · Feb 1989
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
K882480 · International Technidyne Corp. · Aug 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
K882481 · International Technidyne Corp. · Aug 1988
VERIFY(R) REFERENCE PLASMA
K881348 · Organon Teknika Corp. · May 1988