BIOTROL RUB-E.I.A. TEST G— 510(k) K894544

Substantially Equivalent

Biotrol, USA, Inc.

FDA 510(k) clearance K894544 for BIOTROL RUB-E.I.A. TEST G, Substantially Equivalent on 1989-08-30. Applicant: Biotrol, USA, Inc.. Device class: 2.

Clearance details

Applicant: Biotrol, USA, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1989-07-20
Decision date: 1989-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westchester, 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.