CALIBRATOR 282— 510(k) K831872

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K831872 for CALIBRATOR 282, Substantially Equivalent on 1983-07-18. Applicant: Bionostics, Inc.. Device class: 2.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code KRZ
Device class: Class 2
Regulation: 21 CFR 864.8165
Advisory panel: Hematology
Date received: 1983-06-13
Decision date: 1983-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.