Cleared Traditional

K883570 - HISTO-CHECK FUNGAL CONTROL SLIDES
(FDA 510(k) Clearance)

K883570 · Val Tech Diagnostics, Inc. · Microbiology

Oct 1988

Decision

45d

Days

Class 1

Risk

K883570 is an FDA 510(k) clearance for the HISTO-CHECK FUNGAL CONTROL SLIDES. This device is classified as a Quality Control Slides (Class I — General Controls, product code LJG).

Submitted by Val Tech Diagnostics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 6, 1988, 45 days after receiving the submission on August 22, 1988.

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

Submission Details

510(k) Number	K883570 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 22, 1988
Decision Date	October 06, 1988
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—