Cleared Traditional

K951823 - CRYO CHECK LOW FIBRINOGEN CONTROL

K951823 is an FDA 510(k) clearance for CRYO CHECK LOW FIBRINOGEN CONTROL, manufactured by Precision Biologicals, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K951823 · Precision Biologicals, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
258d
Days
Class 2
Risk

K951823 is an FDA 510(k) clearance for the CRYO CHECK LOW FIBRINOGEN CONTROL. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Precision Biologicals, Inc. (Dartmouth, Nova Scotia, CA). The FDA issued a Cleared decision on January 3, 1996 after a review of 258 days - an extended review 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: 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 Precision Biologicals, Inc. devices

FDA 510(k) Submission Details - K951823

510(k) Number K951823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1995
Decision Date January 03, 1996
Days to Decision 258 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
145d slower than avg
Panel avg: 113d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K951823.
BEHRING COAGULATION TIMER
K955278 · Behring Diagnostics, Inc. · May 1996
TAS HMT CONTROLS
K960234 · Cardiovascular Diagnostics, Inc. · May 1996
PORCINE FACTOR VIII
K952321 · Helena Laboratories · Mar 1996
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
K952622 · Precision Biologicals, Inc. · Oct 1995
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
K940209 · Ortho Diagnostic Systems, Inc. · May 1995
STA SYSTEM CONTROL [N] + [P] KIT
K943518 · American Bioproducts Co. · Mar 1995