Cleared Traditional

K781122 - LIPOPROTEIN STAIN (FDA 510(k) Clearance)

Class I Microbiology device.

K781122 · Electrophoresis Corp. of America · Microbiology device
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Aug 1978
Decision
59d
Days
Class 1
Risk

K781122 is an FDA 510(k) clearance for the LIPOPROTEIN STAIN. Classified as Oil Red O (product code HZG), Class I - General Controls.

Submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.1850 - the FDA microbiology 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 Electrophoresis Corp. of America devices

Submission Details

510(k) Number K781122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 31, 1978
Days to Decision 59 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 102d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HZG Oil Red O
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.