Cleared Traditional

K780810 - MLA ELECTRA 750 COAGULATION TIMER

K780810 is the FDA 510(k) clearance for MLA ELECTRA 750 COAGULATION TIMER by Medical Laboratory Automation Systems, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K780810 · Medical Laboratory Automation Systems, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
27d
Days
Class 2
Risk

K780810 is an FDA 510(k) clearance for the MLA ELECTRA 750 COAGULATION TIMER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1978 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 K780810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1978
Decision Date June 14, 1978
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K780810.
ELVI 818 DIGICLOT MULTISCAN
K791586 · Volu Sol Medical Industries · Sep 1979
COAG-A-MATE 2001
K790323 · General Diagnostics · Mar 1979
PLASMA, STANDARDIZED NORMAL
K790204 · Dade, Baxter Travenol Diagnostics, Inc. · Mar 1979
TPC-LYOPHILIZED POOLED HUMAN PLASMA
K761091 · Bio/Data Corp. · Feb 1977
VERONAL BUFFER
K761171 · Bio/Data Corp. · Jan 1977
TRIS BUFFERED SALINE
K761172 · Bio/Data Corp. · Jan 1977