Cleared Traditional

K930148 - TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)

K930148 is an FDA 510(k) clearance for TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIA..., manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K930148 · Heraeus Kulzer, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
119d
Days
Class 2
Risk

K930148 is an FDA 510(k) clearance for the TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 119 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K930148

510(k) Number K930148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date May 11, 1993
Days to Decision 119 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
6d slower than avg
Panel avg: 113d · This submission: 119d
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 309
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K930148.
SIMULTEST CD3/ANTI-HLA-DR
K924587 · Becton Dickinson Immunocytometry Systems · Aug 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON
K926124 · Coulter Corp. · Jul 1993
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA
K925344 · Coulter Corp. · Jan 1993
CD4 CYTOSPHERES KIT
K921279 · Coulter Electronics, Inc. · Dec 1992
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992