Cleared Traditional

K895373 - HEMATOLOGY CONTROL

K895373 is an FDA 510(k) clearance for HEMATOLOGY CONTROL, manufactured by Medical Specialties Intl., Inc.. The device is a Class 2 Hematology device with product code JCN cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K895373 · Medical Specialties Intl., Inc. · Hematology device
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Oct 1989
Decision
38d
Days
Class 2
Risk

K895373 is an FDA 510(k) clearance for the HEMATOLOGY CONTROL. Classified as Control, Cell Counter, Normal And Abnormal (product code JCN), Class II - Special Controls.

Submitted by Medical Specialties Intl., Inc. (South Plainfield, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 38 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Specialties Intl., Inc. devices

FDA 510(k) Submission Details - K895373

510(k) Number K895373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1989
Decision Date October 06, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 113d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCN Device Classification - Class 2, Special Controls

Product Code JCN Control, Cell Counter, Normal And Abnormal
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 - JCN Control, Cell Counter, Normal And Abnormal

All 9
Devices cleared under the same product code (JCN) and FDA review panel - the closest regulatory comparables to K895373.
CELL-DYN 3000 CONTROL
K902391 · Unipath , Ltd. · Aug 1990
PARA 12 PLUS
K901875 · Streck Laboratories, Inc. · May 1990
PARA TECH FOR TECHNICON H-1
K896154 · Streck Laboratories, Inc. · Nov 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907 · R&D Systems, Inc. · Apr 1989
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386 · R&D Systems, Inc. · Dec 1987