SECONDARY CALIBRATORS— 510(k) K904698

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K904698 for SECONDARY CALIBRATORS, Substantially Equivalent on 1990-11-28. Applicant: Bionostics, Inc.. Device class: 2.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1990-10-16
Decision date: 1990-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

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