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."
49–72 of 73
Search insights Median review: 65d Cleared: 100% Top manufacturer: Unipath , Ltd. Lead specialty: Chemistry
Cleared Oct 12, 1989
CLEARPLAN EASY
K894579 · CEP
Unipath , Ltd.
Chemistry · 80d
Cleared Jun 23, 1989
CLEARVIEW STREP A
K893422 · GTZ
Unipath , Ltd.
Microbiology · 52d
Cleared Mar 06, 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
K890675 · CZW
Unipath , Ltd.
Immunology · 25d
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180 · DHR
Unipath , Ltd.
Immunology · 126d
Cleared Dec 20, 1988
TURBOX FIBRINOGEN
K884179 · KQJ
Unipath , Ltd.
Hematology · 81d
Cleared Dec 20, 1988
TURBOX ANTITHROMBIN III
K884144 · JBQ
Unipath , Ltd.
Hematology · 81d
Cleared Nov 10, 1988
TURBOX THEOPHYLLINE ASSAY
K882570 · LER
Unipath , Ltd.
Toxicology · 141d
Cleared Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
K883540 · KTN
Unipath , Ltd.
Immunology · 62d
Cleared Oct 06, 1988
CLEARVIEW HCG
K883777 · JHI
Unipath , Ltd.
Chemistry · 30d
Cleared Jul 28, 1988
CLEARBLUE EASY
K882416 · LCX
Unipath , Ltd.
Chemistry · 45d
Cleared Oct 20, 1987
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · LKL
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
HAPTOGLOBIN
K873866 · DAD
Unipath , Ltd.
Immunology · 57d
Cleared Oct 20, 1987
ALBUMIN IN SERUM
K873862 · DCF
Unipath , Ltd.
Immunology · 57d
Cleared Oct 13, 1987
IMMUNOGLOBULINS M
K873871 · DFT
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS G
K873870 · DEW
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
IMMUNOGLOBULINS A
K873869 · CZP
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
TRANSFERRIN
K873867 · DDG
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
CRP
K873865 · DCK
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN B
K873864 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
APOLIPOPROTEIN A1
K873863 · MSJ
Unipath , Ltd.
Immunology · 50d
Cleared Oct 13, 1987
ALBUMIN IN URINE
K873861 · DCF
Unipath , Ltd.
Immunology · 50d
Cleared Sep 23, 1987
TURBOX
K873401 · JZW
Unipath , Ltd.
Hematology · 30d
Cleared Aug 05, 1987
CLEARPLAN
K871332 · CEP
Unipath , Ltd.
Chemistry · 124d
Cleared Jan 09, 1987
CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)
K864373 · LCX
Unipath , Ltd.
Chemistry · 65d