RDI HS CRP KIT— 510(k) K021609

Substantially Equivalent

Reference Diagnostics, Inc.

FDA 510(k) clearance K021609 for RDI HS CRP KIT, Substantially Equivalent on 2002-06-27. Applicant: Reference Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Reference Diagnostics, Inc.
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2002-05-16
Decision date: 2002-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Reference Diagnostics, Inc.

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K030044 — EXTENDED RANGE HS CRP KIT, CAT NO:92002003-09-30
K030772 — RDI EXTENDED RANGE CRP CALIBRATOR SET2003-04-11

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