Cleared Traditional

K964452 - HEMATACHEK

K964452 is an FDA 510(k) clearance for HEMATACHEK, manufactured by Richmond Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GLK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K964452 · Richmond Diagnostics, Inc. · Hematology device
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Feb 1997
Decision
106d
Days
Class 2
Risk

K964452 is an FDA 510(k) clearance for the HEMATACHEK. Classified as Control, Hematocrit (product code GLK), Class II - Special Controls.

Submitted by Richmond Diagnostics, Inc. (New Brunswick, US). The FDA issued a Cleared decision on February 20, 1997 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 Richmond Diagnostics, Inc. devices

FDA 510(k) Submission Details - K964452

510(k) Number K964452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date February 20, 1997
Days to Decision 106 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
7d faster than avg
Panel avg: 113d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GLK Device Classification - Class 2, Special Controls

Product Code GLK Control, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - GLK Control, Hematocrit

Devices cleared under the same product code (GLK) and FDA review panel - the closest regulatory comparables to K964452.
EUROTROL HEMATOCRIT CONTROL
K121467 · Eurotrol B.V. · May 2013
MEDICA EASYQC HEMATOCRIT CONTROL
K021924 · Bionostics, Inc. · Jun 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · Aalto Scientific, Ltd. · May 2002
CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
K961807 · Ciba Corning Diagnostics Corp. · Jul 1996
MSI-HCT
K924926 · Medical Specialties, Inc. · Jan 1993
A.QC HCT LEVEL 1 AND 2
K893562 · Johnson & Johnson Professionals, Inc. · Jul 1989