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

36 devices

26-36 of 36

Cleared Jul 18, 1994

QUICKVUE IN-LINE ONE-STEP STREP A TEST

Microbiology · 307d

Cleared Feb 21, 1992

QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)

Microbiology · 56d

Cleared Sep 16, 1991

QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST

Microbiology · 105d

Cleared Aug 07, 1991

GROUP A STREP POSITIVE AND NEGATIVE CONTROLS

Microbiology · 40d

Cleared May 07, 1991

QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR

Microbiology · 180d

Cleared Apr 17, 1991

QUIDEL HELICOBACTER PYLORI TEST

Microbiology · 278d

Cleared Oct 02, 1990

QUIDEL CHLAMYDIA POSITIVE CONTROL

Microbiology · 46d

Cleared Jul 27, 1990

QUIDEL CHLAMYDIA TEST

Microbiology · 108d

Cleared Feb 16, 1990

QUIDEL GROUP B STREP TEST

Microbiology · 108d

Cleared Oct 12, 1988

QUIDEL GROUP A STREP TEST

Microbiology · 23d

Cleared Sep 29, 1987

Microbiology · 62d