Cleared Traditional

K951536 - HYDRAGEL PROTEIN(E) KIT
(FDA 510(k) Clearance)

K951536 · Sebia · Chemistry

Jun 1995

Decision

88d

Days

Class 1

Risk

K951536 is an FDA 510(k) clearance for the HYDRAGEL PROTEIN(E) KIT. This device is classified as a Electrophoretic, Protein Fractionation (Class I — General Controls, product code CEF).

Submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on June 30, 1995, 88 days after receiving the submission on April 3, 1995.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1630.

Submission Details

510(k) Number	K951536 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 03, 1995
Decision Date	June 30, 1995
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement