Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

73 results for "Unipath , Ltd."

1–24 of 73

Search insights Median review: 65d Cleared: 100% Top manufacturer: Unipath , Ltd. Lead specialty: Chemistry

Cleared Jul 03, 2006

E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

Chemistry · 10d

Cleared May 25, 2006

CLEARBLUE EASY DIGITAL PREGNANCY TEST

Chemistry · 127d

Cleared Dec 06, 2005

INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC

Microbiology · 169d

Cleared May 12, 2005

E.P.T. CERTAINTY PREGNANCY TEST

Chemistry · 28d

Cleared Sep 10, 2004

FACT PLUS ONE-STEP PREGNANCY TEST KIT

Chemistry · 18d

Cleared Jun 08, 2004

CLEARBLUE EASY EASY READ PREGNANCY TEST

Chemistry · 13d

Cleared Mar 08, 2004

CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST

Chemistry · 25d

Cleared Mar 08, 2004

MODIFICATION TO E.P.T. PREGNANCY TEST

Chemistry · 26d

Cleared Jan 16, 2004

E.P.T. PREGNANCY TEST

Chemistry · 56d

Cleared Oct 20, 2003

EPT CERTAINTY PREGNANCY TEST

Chemistry · 28d

Cleared May 02, 2003

CLEARBLUE EASY DIGITAL PREGNANCY TEST

Chemistry · 60d

Cleared Nov 27, 2002

CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

Chemistry · 23d

Cleared Feb 19, 2002

CLEARPLANE EASY OVULATION TEST

Chemistry · 90d

Cleared Nov 09, 2001

CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

Chemistry · 29d

Cleared Dec 16, 1999

CLEARPLAN EASY II HOME PREGNANCY TEST

Chemistry · 73d

Cleared Dec 02, 1999

CLEARVIEW EASY HCG PREGNANCY TEST

Chemistry · 30d

Cleared Apr 07, 1999

CLEARPLAN EASY HOME PREGNANCY TEST

Chemistry · 70d

Cleared Feb 24, 1999

MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR

Chemistry · 30d

Cleared Dec 10, 1998

Immunology · 190d

Cleared Oct 28, 1998

CLEARPLAN EASY FERTILITY MONITOR

Chemistry · 209d

Cleared Jun 25, 1998

CLEARPLAN EASY OVULATION TEST

Chemistry · 79d

Cleared Feb 07, 1997

CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Microbiology · 91d

Cleared Feb 07, 1997

CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Microbiology · 91d

Cleared Feb 07, 1997

NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Microbiology · 92d