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."
25–48 of 73
Search insights Median review: 65d Cleared: 100% Top manufacturer: Unipath , Ltd. Lead specialty: Chemistry
Cleared Feb 07, 1997
AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964490 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · JTN
Unipath , Ltd.
Microbiology · 91d
Cleared Feb 07, 1997
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964487 · JTN
Unipath , Ltd.
Microbiology · 92d
Cleared Feb 06, 1997
CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964512 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964501 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC
K964496 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Feb 06, 1997
OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964493 · JTN
Unipath , Ltd.
Microbiology · 90d
Cleared Dec 16, 1996
STREPTOLEX-STAT
K962296 · GTZ
Unipath , Ltd.
Microbiology · 187d
Cleared Sep 13, 1996
CLEARVIEW C. DIFF A
K955067 · MCB
Unipath , Ltd.
Microbiology · 312d
Cleared Apr 29, 1996
CLEARBLUE EASY
K960316 · LCX
Unipath , Ltd.
Chemistry · 97d
Cleared Jul 28, 1994
STAPHYTECT-OD
K940557 · LHJ
Unipath , Ltd.
Microbiology · 171d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923 · JJX
Unipath , Ltd.
Chemistry · 77d
Cleared Dec 29, 1993
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922 · JJX
Unipath , Ltd.
Chemistry · 77d
Cleared May 11, 1993
CLEARVIEW HCG
K924673 · JHI
Unipath , Ltd.
Chemistry · 237d
Cleared Nov 22, 1991
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
K913305 · GKZ
Unipath , Ltd.
Hematology · 120d
Cleared Oct 25, 1991
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · JHI
Unipath , Ltd.
Chemistry · 51d
Cleared May 15, 1991
CLEARVIEW HCG SERUM/URINE
K905741 · JHI
Unipath , Ltd.
Chemistry · 142d
Cleared May 06, 1991
CLEARBLUE EASY
K911566 · LCX
Unipath , Ltd.
Chemistry · 27d
Cleared Apr 01, 1991
CLEARVIEW HCG
K910946 · JHJ
Unipath , Ltd.
Chemistry · 26d
Cleared Feb 13, 1991
CLEARBLUE EASY
K905742 · LCX
Unipath , Ltd.
Chemistry · 51d
Cleared Oct 04, 1990
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY
K903665 · GKZ
Unipath , Ltd.
Hematology · 50d
Cleared Sep 10, 1990
CELL-DYN CALIBRATOR
K902892 · KRZ
Unipath , Ltd.
Hematology · 70d
Cleared Aug 22, 1990
CELL-DYN 3000 CONTROL
K902391 · JCN
Unipath , Ltd.
Hematology · 84d
Cleared Jan 29, 1990
CLEARVIEW CHLAMYDIA
K895280 · LJC
Unipath , Ltd.
Microbiology · 158d