ROTA-STAT— 510(k) K864811

Substantially Equivalent

Intl. Diagnostic Laboratories, Ltd.

FDA 510(k) clearance K864811 for ROTA-STAT, Substantially Equivalent on 1987-08-25. Applicant: Intl. Diagnostic Laboratories, Ltd..

Clearance details

Applicant: Intl. Diagnostic Laboratories, Ltd.
Product code: Code LIQ
Advisory panel: Microbiology
Date received: 1986-12-09
Decision date: 1987-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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