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FDA 510(k)

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

K-Number: K971349 · 1997-07-07

ApplicantPrinceton BioMeditech Corp.
Decision Date1997-07-07
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST 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 1997-07-07 under 510(k) number K971349. 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 BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST?

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 1997-07-07. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K971349.

When did BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST receive FDA 510(k) clearance?

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST received FDA 510(k) clearance on 1997-07-07, under 510(k) number K971349.

Who is the listed applicant for BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST?

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 BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST?

The FDA product code for BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST is GTY.

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Other records listing Princeton BioMeditech Corp. as applicant

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Related Devices (Code: GTY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260342AllTest Strep A Rapid TestHangzhou AllTest Biotech Co., Ltd.K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc.K212623Healgen Strep A Rapid Test Strip (Throat Swab)Healgen Scientific,, LLCK171976Sofia Strep A+ FIA, Sofia 2 AnalyzerQuidel CorporationK123793SOFIA STREP A FIAQuidel CorporationK122718BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREPBecton, Dickinson and Company

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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