Medical Device Manufacturer · GB , Bedford Mk41 Oqg

Unipath , Ltd.

73 submissions · 73 cleared · Since 1986
73
Total
73
Cleared
0
Denied

Unipath , Ltd. — FDA 510(k) Submissions

Unipath , Ltd. has submitted 73 FDA 510(k) premarket notifications since 1986, of which 73 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Test, Pregnancy, Hcg, Over The Counter, Susceptibility Test Discs, Antimicrobial, Visual, Pregnancy Hcg, Prescription Use, Radioimmunoassay, Luteinizing Hormone, Counter, Differential Cell . Use the specialty filter in the sidebar to narrow results.

73 devices
1–25 of 73
E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
K061769 · LCX Kit, Test, Pregnancy,... · Chemistry
Jul 2006 10d
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K060128 · LCX Kit, Test, Pregnancy,... · Chemistry
May 2006 127d
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K051638 · GTY Antigens, All Groups,... · Microbiology
Dec 2005 169d
E.P.T. CERTAINTY PREGNANCY TEST
K050930 · LCX Kit, Test, Pregnancy,... · Chemistry
May 2005 28d
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · LCX Kit, Test, Pregnancy,... · Chemistry
Sep 2004 18d
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404 · LCX Kit, Test, Pregnancy,... · Chemistry
Jun 2004 13d
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · LCX Kit, Test, Pregnancy,... · Chemistry
Mar 2004 26d
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · LCX Kit, Test, Pregnancy,... · Chemistry
Mar 2004 25d
E.P.T. PREGNANCY TEST
K033658 · LCX Kit, Test, Pregnancy,... · Chemistry
Jan 2004 56d
EPT CERTAINTY PREGNANCY TEST
K032939 · LCX Kit, Test, Pregnancy,... · Chemistry
Oct 2003 28d
CLEARBLUE EASY DIGITAL PREGNANCY TEST
K030659 · LCX Kit, Test, Pregnancy,... · Chemistry
May 2003 60d
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · LCX Kit, Test, Pregnancy,... · Chemistry
Nov 2002 23d
CLEARPLANE EASY OVULATION TEST
K013874 · CEP Radioimmunoassay,... · Chemistry
Feb 2002 90d
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · LCX Kit, Test, Pregnancy,... · Chemistry
Nov 2001 29d
CLEARPLAN EASY II HOME PREGNANCY TEST
K993333 · LCX Kit, Test, Pregnancy,... · Chemistry
Dec 1999 73d
CLEARVIEW EASY HCG PREGNANCY TEST
K993703 · JHI Visual, Pregnancy Hcg,... · Chemistry
Dec 1999 30d
CLEARPLAN EASY HOME PREGNANCY TEST
K990262 · LCX Kit, Test, Pregnancy,... · Chemistry
Apr 1999 70d
MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR
K990223 · NGE Test, Luteinizing Hormone... · Chemistry
Feb 1999 30d
CLEARVIEW IM
K981946 · KTN System, Test, Infectious... · Immunology
Dec 1998 190d
CLEARPLAN EASY FERTILITY MONITOR
K981207 · NGE Test, Luteinizing Hormone... · Chemistry
Oct 1998 209d
CLEARPLAN EASY OVULATION TEST
K981271 · CEP Radioimmunoassay,... · Chemistry
Jun 1998 79d
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964487 · JTN Susceptibility Test... · Microbiology
Feb 1997 92d
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · JTN Susceptibility Test... · Microbiology
Feb 1997 91d
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964490 · JTN Susceptibility Test... · Microbiology
Feb 1997 91d
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964491 · JTN Susceptibility Test... · Microbiology
Feb 1997 92d
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