Cleared Traditional

STAVIP 3000

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

About This 510(k) Submission

K864436 is an FDA 510(k) clearance for the STAVIP 3000, a Apparatus, Electrophoresis, For Clinical Use (Class I — General Controls, product code JJN), submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on March 16, 1987, 124 days after receiving the submission on November 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2485.

Submission Details

510(k) Number K864436 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1986
Decision Date March 16, 1987
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJN — Apparatus, Electrophoresis, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2485