CALIBRATORS— 510(k) K944701

Substantially Equivalent

Diagnostic Reagents, Inc.

FDA 510(k) clearance K944701 for CALIBRATORS, Substantially Equivalent on 1994-11-21. Applicant: Diagnostic Reagents, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Reagents, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1994-09-23
Decision date: 1994-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.