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Unipath , Ltd.

73 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST (K061769)Unipath , Ltd.2006-07-03
CLEARBLUE EASY DIGITAL PREGNANCY TEST (K060128)Unipath , Ltd.2006-05-25
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC (K051638)Unipath , Ltd.2005-12-06
E.P.T. CERTAINTY PREGNANCY TEST (K050930)Unipath , Ltd.2005-05-12
FACT PLUS ONE-STEP PREGNANCY TEST KIT (K042280)Unipath , Ltd.2004-09-10
CLEARBLUE EASY EASY READ PREGNANCY TEST (K041404)Unipath , Ltd.2004-06-08
MODIFICATION TO E.P.T. PREGNANCY TEST (K040329)Unipath , Ltd.2004-03-08
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST (K040341)Unipath , Ltd.2004-03-08
E.P.T. PREGNANCY TEST (K033658)Unipath , Ltd.2004-01-16
EPT CERTAINTY PREGNANCY TEST (K032939)Unipath , Ltd.2003-10-20
CLEARBLUE EASY DIGITAL PREGNANCY TEST (K030659)Unipath , Ltd.2003-05-02
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K023699)Unipath , Ltd.2002-11-27
CLEARPLANE EASY OVULATION TEST (K013874)Unipath , Ltd.2002-02-19
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST (K013372)Unipath , Ltd.2001-11-09
CLEARPLAN EASY II HOME PREGNANCY TEST (K993333)Unipath , Ltd.1999-12-16
CLEARVIEW EASY HCG PREGNANCY TEST (K993703)Unipath , Ltd.1999-12-02
CLEARPLAN EASY HOME PREGNANCY TEST (K990262)Unipath , Ltd.1999-04-07
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR (K990223)Unipath , Ltd.1999-02-24
CLEARVIEW IM (K981946)Unipath , Ltd.1998-12-10
CLEARPLAN EASY FERTILITY MONITOR (K981207)Unipath , Ltd.1998-10-28
CLEARPLAN EASY OVULATION TEST (K981271)Unipath , Ltd.1998-06-25
CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964492)Unipath , Ltd.1997-02-07
CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964495)Unipath , Ltd.1997-02-07
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964491)Unipath , Ltd.1997-02-07
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964490)Unipath , Ltd.1997-02-07
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964487)Unipath , Ltd.1997-02-07
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964489)Unipath , Ltd.1997-02-07
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC (K964496)Unipath , Ltd.1997-02-06
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964493)Unipath , Ltd.1997-02-06
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964501)Unipath , Ltd.1997-02-06
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC (K964512)Unipath , Ltd.1997-02-06
STREPTOLEX-STAT (K962296)Unipath , Ltd.1996-12-16
CLEARVIEW C. DIFF A (K955067)Unipath , Ltd.1996-09-13
CLEARBLUE EASY (K960316)Unipath , Ltd.1996-04-29
STAPHYTECT-OD (K940557)Unipath , Ltd.1994-07-28
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET (K934923)Unipath , Ltd.1993-12-29
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET (K934922)Unipath , Ltd.1993-12-29
CLEARVIEW HCG (K924673)Unipath , Ltd.1993-05-11
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER (K913305)Unipath , Ltd.1991-11-22
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF (K914240)Unipath , Ltd.1991-10-25
CLEARVIEW HCG SERUM/URINE (K905741)Unipath , Ltd.1991-05-15
CLEARBLUE EASY (K911566)Unipath , Ltd.1991-05-06
CLEARVIEW HCG (K910946)Unipath , Ltd.1991-04-01
CLEARBLUE EASY (K905742)Unipath , Ltd.1991-02-13
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY (K903665)Unipath , Ltd.1990-10-04
CELL-DYN CALIBRATOR (K902892)Unipath , Ltd.1990-09-10
CELL-DYN 3000 CONTROL (K902391)Unipath , Ltd.1990-08-22
CLEARVIEW CHLAMYDIA (K895280)Unipath , Ltd.1990-01-29
CLEARPLAN EASY (K894579)Unipath , Ltd.1989-10-12
CLEARVIEW STREP A (K893422)Unipath , Ltd.1989-06-23
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 (K890675)Unipath , Ltd.1989-03-06
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K884180)Unipath , Ltd.1989-02-03
TURBOX ANTITHROMBIN III (K884144)Unipath , Ltd.1988-12-20
TURBOX FIBRINOGEN (K884179)Unipath , Ltd.1988-12-20
TURBOX THEOPHYLLINE ASSAY (K882570)Unipath , Ltd.1988-11-10
OXOID INFECTIOUS MONONUCLEOSIS KIT (K883540)Unipath , Ltd.1988-10-19
CLEARVIEW HCG (K883777)Unipath , Ltd.1988-10-06
CLEARBLUE EASY (K882416)Unipath , Ltd.1988-07-28
HAPTOGLOBIN (K873866)Unipath , Ltd.1987-10-20
ALBUMIN IN SERUM (K873862)Unipath , Ltd.1987-10-20
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (K873868)Unipath , Ltd.1987-10-20
TRANSFERRIN (K873867)Unipath , Ltd.1987-10-13
CRP (K873865)Unipath , Ltd.1987-10-13
IMMUNOGLOBULINS G (K873870)Unipath , Ltd.1987-10-13
APOLIPOPROTEIN B (K873864)Unipath , Ltd.1987-10-13
APOLIPOPROTEIN A1 (K873863)Unipath , Ltd.1987-10-13
IMMUNOGLOBULINS A (K873869)Unipath , Ltd.1987-10-13
IMMUNOGLOBULINS M (K873871)Unipath , Ltd.1987-10-13
ALBUMIN IN URINE (K873861)Unipath , Ltd.1987-10-13
TURBOX (K873401)Unipath , Ltd.1987-09-23
CLEARPLAN (K871332)Unipath , Ltd.1987-08-05
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION) (K864373)Unipath , Ltd.1987-01-09
CLEARBLUE PREGNANCY TESTING KIT (K861168)Unipath , Ltd.1986-04-24

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Every clearance here is in the API, with alerts when new ones post.