Princeton BioMeditech Corp. - FDA 510(k) Cleared Devices

Cleared Nov 14, 2025

Status™ COVID-19/Flu A&B

K251538 · SCA

Microbiology · 179d

Cleared Sep 18, 2018

BioSign Flu A+B

K182157 · PSZ

Microbiology · 40d

Cleared Dec 10, 2013

BIOSIGN FLU A + B, STATUS FLU A & B

K133474 · PSZ

Microbiology · 28d

Cleared Sep 09, 2013

BIOSIGN FLU A + B, STATUS FLU A & B

K132465 · PSZ

Microbiology · 33d

Cleared Nov 10, 2010

BIOSIGN FLU A+B

K083746 · PSZ

Microbiology · 693d

Cleared Oct 06, 2008

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A

K082661 · GTY

Microbiology · 24d

Cleared Nov 22, 2004

STATUS FIRST STREP A

K040708 · GTY

Microbiology · 249d

Cleared Nov 25, 1998

BIOSTREP A-DIRECT STREP A ANTIGEN TEST

K983386 · GTY

Microbiology · 60d

Cleared Sep 22, 1998

BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST

K980798 · LYR

Microbiology · 204d

Cleared Jul 07, 1997

BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST

K971349 · GTY

Microbiology · 88d