Cleared Traditional

K953643 - HEMATIL 18 (H-18)

K953643 is an FDA 510(k) clearance for HEMATIL 18 (H-18), manufactured by Texas Intl. Laboratories, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K953643 · Texas Intl. Laboratories, Inc. · Hematology device
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Mar 1996
Decision
231d
Days
Class 2
Risk

K953643 is an FDA 510(k) clearance for the HEMATIL 18 (H-18). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Texas Intl. Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on March 22, 1996 after a review of 231 days - an extended review cycle.

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 Texas Intl. Laboratories, Inc. devices

FDA 510(k) Submission Details - K953643

510(k) Number K953643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date March 22, 1996
Days to Decision 231 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 113d · This submission: 231d
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 K953643.
ABBOTT CELL-DYN 3500R SYSTEM
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ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM
K954570 · Ortho Diagnostic Systems, Inc. · Apr 1996
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE
K955909 · Dako Corp. · Mar 1996
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
K953598 · Serono Diagnostics, Inc. · Mar 1996
FLOW-COUNT COULTER FLUOROSPHERES
K954688 · Coulter Corp. · Feb 1996
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K946055 · Becton Dickinson Immunocytometry Systems · Feb 1996