HISTO-CHECK GRAM NEGATIVE SLIDES— 510(k) K883569

Name: FDA 510(k) clearance K883569
Creator: U.S. Food and Drug Administration
Published: 1988-10-06

Substantially Equivalent

Val Tech Diagnostics, Inc.

FDA 510(k) clearance K883569 for HISTO-CHECK GRAM NEGATIVE SLIDES, Substantially Equivalent on 1988-10-06. Applicant: Val Tech Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Val Tech Diagnostics, Inc.
Product code: Code LJG
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1988-08-22
Decision date: 1988-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.