Cleared Traditional

K881852 - REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170

K881852 is the FDA 510(k) clearance for REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 by Helena Laboratories. It is a Class 1 Chemistry device (product code JJN) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K881852 · Helena Laboratories · Chemistry device
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Jul 1988
Decision
67d
Days
Class 1
Risk

K881852 is an FDA 510(k) clearance for the REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 67 days - a notably fast clearance 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: 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 Helena Laboratories devices

Submission Details

510(k) Number K881852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1988
Decision Date July 08, 1988
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 14
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K881852.
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