Cleared Traditional

WESBLOT PROCESSOR

K874887 · American Bionetics, Inc. · Chemistry
Mar 1988
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K874887 is an FDA 510(k) clearance for the WESBLOT PROCESSOR, a Slide Stainer, Automated (Class I — General Controls, product code KPA), submitted by American Bionetics, Inc. (Hayward, US). The FDA issued a Cleared decision on March 24, 1988, 114 days after receiving the submission on December 1, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number K874887 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1987
Decision Date March 24, 1988
Days to Decision 114 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KPA — Slide Stainer, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3800