Cleared Traditional

K924405 - CONTROL PLASMA P

K924405 is an FDA 510(k) clearance for CONTROL PLASMA P, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GGC cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K924405 · Behring Diagnostics, Inc. · Hematology device
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Dec 1992
Decision
92d
Days
Class 2
Risk

K924405 is an FDA 510(k) clearance for the CONTROL PLASMA P. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on December 1, 1992 after a review of 92 days - within the typical 510(k) review window.

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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K924405

510(k) Number K924405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date December 01, 1992
Days to Decision 92 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
21d faster than avg
Panel avg: 113d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGC Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K924405.
CONTROL PLASMA U
K924402 · Behring Diagnostics, Inc. · Feb 1994
FACTOR CONTROL [P]
K930959 · American Bioproducts Co. · May 1993
COAG-CONTROL
K930923 · American Bioproducts Co. · Apr 1993
AVK CONTROL I & II
K921665 · American Bioproducts Co. · Jun 1992
DADE(R) PROTEIN C ABNORMAL CONTRAL
K911885 · Baxter Healthcare Corp · Jun 1991
COAGULATION REFERENCE PLASMA, ABNORMAL
K904073 · Medi-Tech, Inc. · Oct 1990