Cleared Traditional

VERSABLOT (K884258) - FDA 510(k) Clearance

Class I Chemistry device.

K884258 · American Bionetics, Inc. · Chemistry device
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Dec 1988
Decision
64d
Days
Class 1
Risk

K884258 is an FDA 510(k) clearance for the VERSABLOT. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by American Bionetics, Inc. (Hayward, US). The FDA issued a Cleared decision on December 14, 1988 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.3800 - 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 American Bionetics, Inc. devices

Submission Details

510(k) Number K884258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1988
Decision Date December 14, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
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.