Cleared Traditional

K925344 - COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA

K925344 is an FDA 510(k) clearance for COULTER NEW METH BLUE PREPREP RETIC/MAX..., manufactured by Coulter Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K925344 · Coulter Corp. · Hematology device
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Jan 1993
Decision
91d
Days
Class 2
Risk

K925344 is an FDA 510(k) clearance for the COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on January 21, 1993 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Coulter Corp. devices

FDA 510(k) Submission Details - K925344

510(k) Number K925344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date January 21, 1993
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKZ Device Classification - Class 2, Special Controls

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K925344.
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · Coulter Corp. · Jul 1993
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · Heraeus Kulzer, Inc. · May 1993
CD4 CYTOSPHERES KIT
K921279 · Coulter Electronics, Inc. · Dec 1992
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992
COULTER MH009
K922181 · Coulter Electronics, Inc. · Aug 1992