FDA.reportPublic FDA data

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.

Matched from indexed company URL: Polymedco, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24355051000119795POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC.1Y2026-01-01510 FURNACE DOCK RD. CORTLANDT MANOR NY US 10567

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
430101084160287P130001Epi proColonPHP2016-04-12
430101983330805K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
430101762597845K980798BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TESTLYR1998-09-22
430101887987897K974845BTA STAT TEST PRESCRIPTION HOME USEMMW1998-12-08
430101601613305K971402BARD BTA TRAK TESTMMW1998-04-15
430101010081165K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
430101217005691K924061CANCER ANTIGEN CONTROLJJY1993-02-23
430101438809755K921206HCG CONTROLJJX1992-04-29
430101150102928K231974PATHFAST®hs-cTnI-IIMMI2024-03-20
430101145711431K191147OC-Auto SENSOR io iFOB TestOOX2020-01-02
430101702070305K143325OC-Light S FITKHE2015-08-20
430101022458178K132465BIOSIGN FLU A + B, STATUS FLU A & BPSZ2013-09-09
430101960614842K100130PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2MMI2011-05-16
430101529632641K092330OC-SENSOR DIANA IFOB TESTOOX2010-01-08
430101037601024K083412PATHFAST HSCRPDCN2009-03-09
430101580227961K081360PATHFAST CK-MB-II, PATHFAST MYO-IIJHX2009-08-17
430101719901624K072288PATHFAST D-DIMERGHH2009-05-06
430101950192677K072189PATHFAST NTPROBNP AND D-DIMER TESTSNBC2008-02-05
430101604224793K041408POLYMEDCO OC AUTO MICRO 80 FOB TESTOOX2004-10-21
430101652356134K041297POLYMEDCO OC LIGHT FOBT TESTKHE2004-08-12
430101338021719K040708STATUS FIRST STREP AGTY2004-11-22
430101113392816K020439STATUS HCG SERUM/URINEJHI2002-05-23
430101365034323K012163POLYTITER SYSTEMDHN2001-08-20
430101143068456
430101308004357
430101534618330
430101680581100
430101715742030
430101728853186
430101862336056
430101949142447

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OOX32020-01-02
MMI22024-03-20
KHE22015-08-20
GTY22004-11-22
MMW21998-12-08
PHP12016-04-12
PSZ12013-09-09
JHX12009-08-17
GHH12009-05-06
DCN12009-03-09
NBC12008-02-05
JHI12002-05-23
DHN12001-08-20
LYR11998-09-22
KTN11997-02-04
JJY11993-02-23
JJX11992-04-29

PMN#

GUDID#

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