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FDA 510(k)

BIOSTREP A-DIRECT STREP A ANTIGEN TEST

K-Number: K983386 · 1998-11-25

ApplicantPrinceton BioMeditech Corp.
Decision Date1998-11-25
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOSTREP 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 1998-11-25 under 510(k) number K983386. 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 BIOSTREP A-DIRECT STREP A ANTIGEN TEST?

BIOSTREP A-DIRECT STREP A ANTIGEN TEST is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K983386.

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

BIOSTREP A-DIRECT STREP A ANTIGEN TEST received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983386.

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

The FDA product code for BIOSTREP A-DIRECT STREP A ANTIGEN TEST 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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