Quidel Corp. - FDA 510(k) Cleared Devices
Recent clearances: QUIDEL MOLECULAR RSV + HMPV ASSAY, QUIDEL MOLECULAR INFLUENZA A + B ASSAY, SOFIA(R) RSV FIA
93
Total
93
Cleared
0
Denied
FDA 510(k) Regulatory Record - Quidel Corp. Chemistry ✕
39 devices
Cleared
Aug 02, 2013
SOFIA(R) HCG FIA
Chemistry
100d
Cleared
Apr 29, 2004
QUICKVUE ADVANCE PH AND AMINES GLL TEST
Chemistry
118d
Cleared
Sep 27, 2002
PH AND AMINES EXTERNAL CONTROL SET
Chemistry
31d
Cleared
May 17, 2002
QUICKVUE ONE-STEP HCG-URINE
Chemistry
66d
Cleared
May 17, 2002
QUICKVUE ONE-STEP HCG-COMBO
Chemistry
66d
Cleared
Jun 03, 1998
QUIDEL HOME PREGNANCY TEST
Chemistry
19d
Cleared
Jan 26, 1998
BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST
Chemistry
34d
Cleared
Dec 19, 1997
QUICKVUE SEMI-Q HCG-COMBO
Chemistry
53d
Cleared
Dec 01, 1997
QUICKVUE ONE-STEP HCG-COMBO
Chemistry
54d
Cleared
Nov 26, 1997
CARDS Q.S. HCG SERUM/URINE
Chemistry
48d
Cleared
Nov 26, 1997
SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSITIVE)
Chemistry
26d
Cleared
Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
Chemistry
37d
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