YEASTEST— 510(k) K993554

Substantially Equivalent

Diagnostic Markers, Inc.

FDA 510(k) clearance K993554 for YEASTEST, Substantially Equivalent on 2000-02-10. Applicant: Diagnostic Markers, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostic Markers, Inc.
Product code: Code JXB
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1999-10-20
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.