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
26-50 of 93
Cleared Jul 29, 1998
QUIDEL CH50 EQ EIA
K974111 · DAE
Immunology · 271d
Cleared Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
K981722 · LCX
Chemistry · 19d
Cleared Jan 26, 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
K974821 · LCX
Chemistry · 34d
Cleared Dec 19, 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052 · JHI
Chemistry · 53d
Cleared Dec 01, 1997
QUICKVUE ONE-STEP HCG-COMBO
K973841 · JHI
Chemistry · 54d
Cleared Nov 26, 1997
CARDS Q.S. HCG SERUM/URINE
K973858 · JHI
Chemistry · 48d
Cleared Nov 26, 1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
K974108 · JJX
Chemistry · 26d
Cleared Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
K972742 · JHI
Chemistry · 37d
Cleared Aug 29, 1997
CARDS Q.S. HCG-URINE
K972748 · JHI
Chemistry · 37d
Cleared Apr 15, 1996
CARDS Q.S. STREP A
K955108 · GTZ
Microbiology · 159d
Cleared Feb 06, 1996
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517 · LYR
Microbiology · 251d
Cleared Oct 20, 1995
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
K954257 · GTZ
Microbiology · 85d
Cleared Oct 16, 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · JHI
Chemistry · 33d
Cleared Oct 13, 1995
CAMEO HOME PREGNANCY TEST
K954364 · LCX
Chemistry · 25d
Cleared Oct 02, 1995
QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728 · DHB
Immunology · 228d
Cleared Aug 23, 1995
CONCEIVE OVULATION PREDICTOR
K953063 · CEP
Chemistry · 54d
Cleared May 19, 1995
QUICKVUE(R) CHLAMYDIA TEST
K946276 · LJC
Microbiology · 147d
Cleared Feb 10, 1995
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB...
K945080 · GTY
Microbiology · 116d
Cleared Jan 27, 1995
RAPIDVUE(TM) HCG
K945969 · JHI
Chemistry · 51d
Cleared Jul 18, 1994
QUICKVUE IN-LINE ONE-STEP STREP A TEST
K934484 · GTZ
Microbiology · 307d
Cleared Jun 29, 1993
QUICKVUE ONE-STEP HCG COMBO
K932042 · JHI
Chemistry · 63d
Cleared Jun 22, 1993
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
K931761 · JJX
Chemistry · 75d
Cleared Dec 28, 1992
CONCEIVE ONE-STEP PREGNANCY TEST
K925096 · LCX
Chemistry · 81d
Cleared Dec 03, 1992
QUICKVUE ONE-STEP HCG TEST
K925435 · JHI
Chemistry · 36d
Cleared Mar 11, 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · CEP
Chemistry · 57d

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