Cleared Traditional

VERSABLOT

K884258 · American Bionetics, Inc. · Chemistry

Dec 1988

Decision

64d

Days

Class 1

Risk

About This 510(k) Submission

K884258 is an FDA 510(k) clearance for the VERSABLOT, 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 December 14, 1988, 64 days after receiving the submission on October 11, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number	K884258 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 1988
Decision Date	December 14, 1988
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—