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FDA 510(k)

STATUS FIRST STREP A

K-Number: K040708 · 2004-11-22

ApplicantPrinceton BioMeditech Corp.
Decision Date2004-11-22
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STATUS FIRST STREP A is the device name listed in this FDA 510(k) record. The listed applicant is Princeton BioMeditech Corp.. It received FDA 510(k) clearance on 2004-11-22 under 510(k) number K040708. The device is classified under product code GTY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATUS FIRST STREP A?

STATUS FIRST STREP A is a medical device that received FDA 510(k) clearance on 2004-11-22. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K040708.

When did STATUS FIRST STREP A receive FDA 510(k) clearance?

STATUS FIRST STREP A received FDA 510(k) clearance on 2004-11-22, under 510(k) number K040708.

Who is the listed applicant for STATUS FIRST STREP A?

The FDA 510(k) record lists Princeton BioMeditech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATUS FIRST STREP A?

The FDA product code for STATUS FIRST STREP A is GTY.

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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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