Cleared Traditional

K781062 - DROPPER, SOLUTION TRICHROME, CEPTI-SEAL (FDA 510(k) Clearance)

Class I Chemistry device.

K781062 · Marion Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1978
Decision
49d
Days
Class 1
Risk

K781062 is an FDA 510(k) clearance for the DROPPER, SOLUTION TRICHROME, CEPTI-SEAL. Classified as Stain, Trichrome, Mallory's (product code HYW), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.1850 - the FDA in vitro diagnostics and chemistry 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 Marion Laboratories, Inc. devices

Submission Details

510(k) Number K781062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1978
Decision Date August 14, 1978
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HYW Stain, Trichrome, Mallory's
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.