Cleared Traditional

K882371 - SOC SLIDE CULTURE SYSTEM
(FDA 510(k) Clearance)

K882371 · The Cancer Center AT Wadley Institutes · Microbiology device

Jul 1988

Decision

40d

Days

Class 1

Risk

K882371 is an FDA 510(k) clearance for the SOC SLIDE CULTURE SYSTEM. This device is classified as a Kit, Screening, Yeast (Class I - General Controls, product code JXC).

Submitted by The Cancer Center AT Wadley Institutes (Dallas, US). The FDA issued a Cleared decision on July 18, 1988, 40 days after receiving the submission on June 8, 1988.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K882371 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 08, 1988
Decision Date	July 18, 1988
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—