Unipath , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: E.P.T. CERTAINTY 1-STEP PREGNANCY TEST, CLEARBLUE EASY DIGITAL PREGNANCY TEST, INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
73
Total
73
Cleared
0
Denied
FDA 510(k) Regulatory Record - Unipath , Ltd. Immunology ✕
15 devices
Cleared
Dec 10, 1998
CLEARVIEW IM
Immunology
190d
Cleared
Mar 06, 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
Immunology
25d
Cleared
Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Immunology
126d
Cleared
Oct 19, 1988
OXOID INFECTIOUS MONONUCLEOSIS KIT
Immunology
62d
Cleared
Oct 20, 1987
ALBUMIN IN SERUM
Immunology
57d
Cleared
Oct 20, 1987
HAPTOGLOBIN
Immunology
57d
Cleared
Oct 20, 1987
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
Immunology
57d
Cleared
Oct 13, 1987
ALBUMIN IN URINE
Immunology
50d
Cleared
Oct 13, 1987
APOLIPOPROTEIN A1
Immunology
50d
Cleared
Oct 13, 1987
APOLIPOPROTEIN B
Immunology
50d
Cleared
Oct 13, 1987
CRP
Immunology
50d
Cleared
Oct 13, 1987
TRANSFERRIN
Immunology
50d
Cleared
Oct 13, 1987
IMMUNOGLOBULINS A
Immunology
50d
Cleared
Oct 13, 1987
IMMUNOGLOBULINS G
Immunology
50d
Cleared
Oct 13, 1987
IMMUNOGLOBULINS M
Immunology
50d