RDI EXTENDED RANGE CRP CALIBRATOR SET— 510(k) K030772

Name: FDA 510(k) clearance K030772
Creator: U.S. Food and Drug Administration
Published: 2003-04-11

Substantially Equivalent

Reference Diagnostics, Inc.

FDA 510(k) clearance K030772 for RDI EXTENDED RANGE CRP CALIBRATOR SET, Substantially Equivalent on 2003-04-11. Applicant: Reference Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Reference Diagnostics, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2003-03-11
Decision date: 2003-04-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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