PREG-PHILE B— 510(k) K821676

Substantially Equivalent

Bio Diagnostic Systems, Inc.

FDA 510(k) clearance K821676 for PREG-PHILE B, Substantially Equivalent on 1982-07-16. Applicant: Bio Diagnostic Systems, Inc..

Clearance details

Applicant
Bio Diagnostic Systems, Inc.
Product code
Code JHJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

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