Cleared Traditional

K934741 - LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2

K934741 is an FDA 510(k) clearance for LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2, manufactured by Clinical Controls, Inc.. The device is a Class 2 Hematology device with product code GIL cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K934741 · Clinical Controls, Inc. · Hematology device
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Sep 1994
Decision
342d
Days
Class 2
Risk

K934741 is an FDA 510(k) clearance for the LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2. Classified as Plasma, Fibrinogen Control (product code GIL), Class II - Special Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on September 8, 1994 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - 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. Elevated predicate reliance profile. 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 Clinical Controls, Inc. devices

FDA 510(k) Submission Details - K934741

510(k) Number K934741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1993
Decision Date September 08, 1994
Days to Decision 342 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
229d slower than avg
Panel avg: 113d · This submission: 342d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIL Device Classification - Class 2, Special Controls

Product Code GIL Plasma, Fibrinogen Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
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 - GIL Plasma, Fibrinogen Control

All 7
Devices cleared under the same product code (GIL) and FDA review panel - the closest regulatory comparables to K934741.
FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
K946265 · Clinical Controls, Inc. · Aug 1995
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K935598 · Clinical Controls, Inc. · May 1995
N/T PROTEIN CONTROL PY
K951012 · Behring Diagnostics, Inc. · Apr 1995
FIBRINOGEN CONTROL
K915462 · Sigma Diagnostics, Inc. · Mar 1992
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
K833352 · Warner-Lambert Co. · Nov 1983