Cleared Traditional

K882344 - ELECTR-TRANSBLOTTER

K882344 is an FDA 510(k) clearance for ELECTR-TRANSBLOTTER, manufactured by The W.E.P. Co.. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K882344 · The W.E.P. Co. · Chemistry device
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Jan 1989
Decision
220d
Days
Class 1
Risk

K882344 is an FDA 510(k) clearance for the ELECTR-TRANSBLOTTER. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by The W.E.P. Co. (Seattle, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 220 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2485 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all The W.E.P. Co. devices

FDA 510(k) Submission Details - K882344

510(k) Number K882344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1988
Decision Date January 13, 1989
Days to Decision 220 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 88d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

JJN Device Classification - Class 1, General Controls

Product Code JJN Apparatus, Electrophoresis, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2485
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.

Regulatory Peers - JJN Apparatus, Electrophoresis, For Clinical Use

All 24
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