Cleared Traditional

K924403 - CONTROL PLASMA N

K924403 is the FDA 510(k) clearance for CONTROL PLASMA N by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code GIZ) cleared through the Traditional 510(k) pathway after a 540-day FDA review.

K924403 · Behring Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
540d
Days
Class 2
Risk

K924403 is an FDA 510(k) clearance for the CONTROL PLASMA N. Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 540 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K924403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1992
Decision Date February 22, 1994
Days to Decision 540 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
427d slower than avg
Panel avg: 113d · This submission: 540d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIZ Plasma, Control, Normal
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 - GIZ Plasma, Control, Normal

All 12
Devices cleared under the same product code (GIZ) and FDA review panel - the closest regulatory comparables to K924403.
CONTROL PLASMA N
K001256 · Dade Behring, Inc. · May 2000
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · Sigma Diagnostics, Inc. · Oct 1997
SPECIALTY ASSAYED CONTROL-1
K941737 · Helena Laboratories · Oct 1994
COAGULATION REFERENCE PLASMA, NORMAL
K932145 · American Diagnostic Corp. · Oct 1993
UNICALIBRATOR KIT
K922021 · American Bioproducts Co. · Jun 1992
COAGULATION REFERENCE PLASMA, NORMAL
K905203 · Medical Diagnostic Technologies, Inc. · Dec 1990