Cleared Traditional

MICROSAMPLE COAGULATION ANALYZER (K943153) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K943153 · Bio/Data Corp. · Hematology device
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Mar 1995
Decision
267d
Days
Class 2
Risk

K943153 is an FDA 510(k) clearance for the MICROSAMPLE COAGULATION ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Bio/Data Corp. (Horsham, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 267 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5400 - 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 Bio/Data Corp. devices

Submission Details

510(k) Number K943153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1994
Decision Date March 24, 1995
Days to Decision 267 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 113d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKP Instrument, Coagulation, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5400
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 - GKP Instrument, Coagulation, Automated

All 48
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K943153.
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ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
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ACL TOP 700 LAS
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ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
K073377 · Instrumentation Laboratory CO · May 2008