Cleared Traditional

LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (K934741) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.