Medical Device Manufacturer · US , Washington , DC

Quidel Corp. - FDA 510(k) Cleared Devices

93 submissions · 93 cleared · Since 1983
93
Total
93
Cleared
0
Denied
93 devices
51-75 of 93
Cleared Feb 21, 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · LYR
Microbiology · 56d
Cleared Sep 16, 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442 · LYR
Microbiology · 105d
Cleared Aug 16, 1991
DIRECTIGEN 1-2-3(TM) HCG TEST
K913122 · JHI
Chemistry · 32d
Cleared Aug 07, 1991
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
K912868 · GTZ
Microbiology · 40d
Cleared May 31, 1991
DIRECTIGEN 1-2-3 PREGNANCY CONTROLS
K911664 · JJX
Chemistry · 49d
Cleared May 07, 1991
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049 · LYR
Microbiology · 180d
Cleared Apr 17, 1991
QUIDEL HELICOBACTER PYLORI TEST
K903099 · LYR
Microbiology · 278d
Cleared Mar 12, 1991
POSITIVE CONTROL PAD FOR TOTAL IGE TEST DIPSTICK
K910082 · DGC
Immunology · 63d
Cleared Jan 14, 1991
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
K905162 · DHB
Immunology · 59d
Cleared Dec 13, 1990
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
K905176 · DHB
Immunology · 24d
Cleared Oct 15, 1990
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
K903738 · DGC
Immunology · 60d
Cleared Oct 02, 1990
QUIDEL CHLAMYDIA POSITIVE CONTROL
K903765 · LJC
Microbiology · 46d
Cleared Jul 27, 1990
QUIDEL CHLAMYDIA TEST
K901660 · LJC
Microbiology · 108d
Cleared Feb 16, 1990
QUIDEL GROUP B STREP TEST
K896265 · GTZ
Microbiology · 108d
Cleared Jan 26, 1990
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS
K896926 · KTN
Immunology · 46d
Cleared Oct 25, 1989
QUIDEL HCG TEST
K894790 · JHI
Chemistry · 89d
Cleared Aug 11, 1989
QUIDEL REFLECTANCE ANALYZER
K893738 · JJQ
Chemistry · 86d
Cleared Jul 28, 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253 · DHB
Immunology · 38d
Cleared Jul 14, 1989
QUIDEL TOTAL IGE TEST QUANTITATIVE VERSION
K894039 · DGO
Immunology · 38d
Cleared Jun 16, 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · KTN
Immunology · 30d
Cleared May 04, 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409 · DHB
Immunology · 27d
Cleared Apr 18, 1989
DIRECTIGEN1-2-3 BHCG PREGNANCY TEST
K890615 · JHI
Chemistry · 70d
Cleared Feb 17, 1989
QUIDEL FOOD ALLERGY SCREEN
K884501 · DHB
Immunology · 114d
Cleared Oct 18, 1988
QUIDEL ALLERGY SCREEN
K883666 · DHB
Immunology · 53d
Cleared Oct 12, 1988
QUIDEL GROUP A STREP TEST
K883999 · GTZ
Microbiology · 23d

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