Cleared Traditional

K910160 - ELECTROPHORESIS CONTROL
(FDA 510(k) Clearance)

K910160 · Seradyn, Inc. · Chemistry

Feb 1991

Decision

43d

Days

Class 2

Risk

K910160 is an FDA 510(k) clearance for the ELECTROPHORESIS CONTROL, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 27, 1991, 43 days after receiving the submission on January 15, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K910160 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 15, 1991
Decision Date	February 27, 1991
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—