Cleared Traditional

K864436 - STAVIP 3000

K864436 is an FDA 510(k) clearance for STAVIP 3000, manufactured by Roseburg SA. The device is a Class 1 Chemistry device with product code JJN cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K864436 · Roseburg SA · Chemistry device
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Mar 1987
Decision
124d
Days
Class 1
Risk

K864436 is an FDA 510(k) clearance for the STAVIP 3000. Classified as Apparatus, Electrophoresis, For Clinical Use (product code JJN), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on March 16, 1987 after a review of 124 days - within the typical 510(k) review window.

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 Roseburg SA devices

FDA 510(k) Submission Details - K864436

510(k) Number K864436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date March 16, 1987
Days to Decision 124 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
36d slower than avg
Panel avg: 88d · This submission: 124d
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 23
Devices cleared under the same product code (JJN) and FDA review panel - the closest regulatory comparables to K864436.
REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
K881852 · Helena Laboratories · Jul 1988
HELENA REP GEL PROCESSOR
K882163 · Helena Laboratories · Jun 1988
RAPID ELECTROPHORESIS SYSTEM (REP)
K873352 · Helena Laboratories · Sep 1987
ELECTROPHORESIS WORK CENTER (EWC)
K861414 · Helena Laboratories · Aug 1986
OPTICLEAR
K842485 · Gelman Sciences, Inc. · Aug 1984
OPTIPHOR-10
K842560 · Gelman Sciences, Inc. · Aug 1984