Cleared Traditional

HISTO-CHECK PARASITIC CONTROL SLIDES

K883571 · Val Tech Diagnostics, Inc. · Microbiology
Oct 1988
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K883571 is an FDA 510(k) clearance for the HISTO-CHECK PARASITIC CONTROL SLIDES, 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 review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K883571 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 —

Device Classification

Product Code LJG — Quality Control Slides
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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