Cleared Traditional

K931206 - ELECTRA 1600C AUTOMATIC COAGULATION TIMER

K931206 is the FDA 510(k) clearance for ELECTRA 1600C AUTOMATIC COAGULATION TIMER 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 166-day FDA review.

K931206 · Medical Laboratory Automation Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
166d
Days
Class 2
Risk

K931206 is an FDA 510(k) clearance for the ELECTRA 1600C AUTOMATIC COAGULATION TIMER. 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 August 23, 1993 after a review of 166 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 Medical Laboratory Automation Systems, Inc. devices

Submission Details

510(k) Number K931206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date August 23, 1993
Days to Decision 166 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
53d slower than avg
Panel avg: 113d · This submission: 166d
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 K931206.
MICROSAMPLE COAGULATION ANALYZER
K943153 · Bio/Data Corp. · Mar 1995
STA AUTOMATED MULTI-PARAMETRIC ANALYZER
K942117 · American Bioproducts Co. · Feb 1995
HEMOLAB
K931992 · Biomerieux Vitek, Inc. · Dec 1994
CASCADE M, CAT. NO. 1710
K931956 · Helena Laboratories · Aug 1993
IL MCL-2 COAGULATION ANALYZER
K924098 · Instrumentation Laboratory CO · Jun 1993
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K921465 · Helena Laboratories · Jun 1992