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FDA 510(k)

RDI HS CRP CALIBRATOR SET

K-Number: K021607 · 2002-06-27

ApplicantReference Diagnostics, Inc.
Decision Date2002-06-27
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RDI HS CRP CALIBRATOR SET is the device name listed in this FDA 510(k) record. The listed applicant is Reference Diagnostics, Inc.. It received FDA 510(k) clearance on 2002-06-27 under 510(k) number K021607. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RDI HS CRP CALIBRATOR SET?

RDI HS CRP CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2002-06-27. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K021607.

When did RDI HS CRP CALIBRATOR SET receive FDA 510(k) clearance?

RDI HS CRP CALIBRATOR SET received FDA 510(k) clearance on 2002-06-27, under 510(k) number K021607.

Who is the listed applicant for RDI HS CRP CALIBRATOR SET?

The FDA 510(k) record lists Reference Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RDI HS CRP CALIBRATOR SET?

The FDA product code for RDI HS CRP CALIBRATOR SET is JIT.

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Other records listing Reference Diagnostics, Inc. as applicant

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Related Devices (Code: JIT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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