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FDA 510(k)

IDI-STREP B ASSAY

K-Number: K022504 · 2002-11-18

ApplicantInfectio Diagnostic, Inc.
Decision Date2002-11-18
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IDI-STREP B ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Infectio Diagnostic, Inc.. It received FDA 510(k) clearance on 2002-11-18 under 510(k) number K022504. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDI-STREP B ASSAY?

IDI-STREP B ASSAY is a medical device that received FDA 510(k) clearance on 2002-11-18. The listed applicant is Infectio Diagnostic, Inc.. The 510(k) number is K022504.

When did IDI-STREP B ASSAY receive FDA 510(k) clearance?

IDI-STREP B ASSAY received FDA 510(k) clearance on 2002-11-18, under 510(k) number K022504.

Who is the listed applicant for IDI-STREP B ASSAY?

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

What is the FDA product code for IDI-STREP B ASSAY?

The FDA product code for IDI-STREP B ASSAY is NJR.

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Official Source

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

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