BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A— 510(k) K082661

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K082661 for BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A, Substantially Equivalent on 2008-10-06. Applicant: Princeton BioMeditech Corp..

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 2008-09-12
Decision date: 2008-10-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Monmouth Junction, NJ, US

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Adverse events under product code GTY

product code GTY

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.