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FDA 510(k)

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A

K-Number: K082661 · 2008-10-06

ApplicantPrinceton BioMeditech Corp.
Decision Date2008-10-06
Product CodeGTY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST 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 2008-10-06 under 510(k) number K082661. 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, BIOSIGN STREP A, STATUSFIRST STREP A?

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A is a medical device that received FDA 510(k) clearance on 2008-10-06. The listed applicant is Princeton BioMeditech Corp.. The 510(k) number is K082661.

When did BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A receive FDA 510(k) clearance?

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A received FDA 510(k) clearance on 2008-10-06, under 510(k) number K082661.

Who is the listed applicant for BIOSTREP A, BIOSIGN STREP A, STATUSFIRST 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 BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A?

The FDA product code for BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A is GTY.

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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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