Cleared Traditional

K962664 - ELECTRA 1800C AUTOMATIC COAGULATION ANA...

K962664 is the FDA 510(k) clearance for ELECTRA 1800C AUTOMATIC COAGULATION ANA... by Medical Laboratory Automation Systems, Inc.. It is a Class 2 Hematology device (product code GKP) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K962664 · Medical Laboratory Automation Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
63d
Days
Class 2
Risk

K962664 is an FDA 510(k) clearance for the ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER. Classified as Instrument, Coagulation, Automated (product code GKP), Class II - Special Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on September 10, 1996 after a review of 63 days - a notably fast clearance 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: 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 Laboratory Automation Systems, Inc. devices

Submission Details

510(k) Number K962664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1996
Decision Date September 10, 1996
Days to Decision 63 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
50d faster than avg
Panel avg: 113d · This submission: 63d
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 37
Devices cleared under the same product code (GKP) and FDA review panel - the closest regulatory comparables to K962664.
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ACL 6000 SYSTEM (ACL 6000)
K961991 · Instrumentation Laboratory CO · Sep 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · American Bioproducts Co. · Jul 1996
PROTIME MICROCOAGULATION SYSTEM
K951072 · International Technidyne Corp. · Oct 1995