Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quidel Corp. — Predicate Candidate Screening
93 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
149 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131813 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Quidel Corp. | 2013-09-06 | 78 | 0 |
| K131728 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Quidel Corp. | 2013-08-29 | 78 | 0 |
| K130398 | SOFIA(R) RSV FIA | Quidel Corp. | 2013-08-13 | 175 | 0 |
| K131166 | SOFIA(R) HCG FIA | Quidel Corp. | 2013-08-02 | 100 | 0 |
| K131606 | SOFIA INFLUENZA A+B FIA | Quidel Corp. | 2013-07-05 | 32 | 0 |
| K131619 | QUICKVUE INFLUENZA A+B | Quidel Corp. | 2013-06-28 | 25 | 0 |
| K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY | Quidel Corp. | 2013-03-08 | 227 | 0 |
| K123998 | QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY | Quidel Corp. | 2013-03-08 | 72 | 0 |
| K113777 | QUIDEL MOLECULAR INFLUENZA A+B | Quidel Corp. | 2012-03-15 | 85 | 0 |
| K112172 | QUIDEL MOLECULAR INFLUENZA A + B ASSAY | Quidel Corp. | 2011-12-22 | 147 | 0 |
| K112490 | QUIDEL MOLECULAR HMPV ASSAY | Quidel Corp. | 2011-12-15 | 108 | 0 |
| K112177 | SOFIA ANALYZER AND INFLUENZA A+B FIA | Quidel Corp. | 2011-10-24 | 88 | 1 |
| K101918 | QUICKVUE RSV 10 | Quidel Corp. | 2010-09-24 | 77 | 0 |
| K092698 | QUICKVUE INFLUENZA A+B TEST | Quidel Corp. | 2009-09-15 | 13 | 0 |
| K070747 | QUICK VUE RSV TEST, MODELS 20193, 20199 | Quidel Corp. | 2007-04-23 | 35 | 0 |
| K061008 | QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL | Quidel Corp. | 2006-09-08 | 149 | 0 |
| K053146 | QUICKVUE INFLUENZA A + B TEST | Quidel Corp. | 2005-12-14 | 34 | 0 |
| K040008 | QUICKVUE ADVANCE PH AND AMINES GLL TEST | Quidel Corp. | 2004-04-29 | 118 | 0 |
| K031899 | QUICKVUE INFLUENZA A+B TEST | Quidel Corp. | 2003-09-11 | 99 | 0 |
| K022851 | PH AND AMINES EXTERNAL CONTROL SET | Quidel Corp. | 2002-09-27 | 31 | 0 |
| K020801 | QUICKVUE ONE-STEP HCG-COMBO | Quidel Corp. | 2002-05-17 | 66 | 0 |
| K020799 | QUICKVUE ONE-STEP HCG-URINE | Quidel Corp. | 2002-05-17 | 66 | 1 |
| K011097 | QUICKVUE DIPSTICK STREP A | Quidel Corp. | 2001-05-08 | 27 | 2 |
| K991633 | QUICKVUE INFLUENZA A/B TEST | Quidel Corp. | 1999-09-24 | 135 | 0 |
| K991747 | QUICKVUE ONE-STEP H. PYLORI II TEST | Quidel Corp. | 1999-08-04 | 75 | 0 |
| K974111 | QUIDEL CH50 EQ EIA | Quidel Corp. | 1998-07-29 | 271 | 0 |
| K981722 | QUIDEL HOME PREGNANCY TEST | Quidel Corp. | 1998-06-03 | 19 | 0 |
| K974821 | BLUETEST(R) PREGNANCY TEST, RAPIDVUE(R) PREGNANCY TEST | Quidel Corp. | 1998-01-26 | 34 | 0 |
| K974052 | QUICKVUE SEMI-Q HCG-COMBO | Quidel Corp. | 1997-12-19 | 53 | 0 |
| K973841 | QUICKVUE ONE-STEP HCG-COMBO | Quidel Corp. | 1997-12-01 | 54 | 0 |
| K974108 | SERUM HCG CONTROL SET (NEGATIVE, LOW POSITIVE AND HIGH POSIT | Quidel Corp. | 1997-11-26 | 26 | 0 |
| K973858 | CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMB | Quidel Corp. | 1997-11-26 | 48 | 0 |
| K972742 | QUICKVUE ONE-STEP HCG-URINE | Quidel Corp. | 1997-08-29 | 37 | 0 |
| K972748 | CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE | Quidel Corp. | 1997-08-29 | 37 | 0 |
| K955108 | CARDS Q.S. STREP A | Quidel Corp. | 1996-04-15 | 159 | 0 |
| K952517 | QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST | Quidel Corp. | 1996-02-06 | 251 | 0 |
| K954257 | QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) | Quidel Corp. | 1995-10-20 | 85 | 0 |
| K954273 | CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG | Quidel Corp. | 1995-10-16 | 33 | 0 |
| K954364 | CAMEO HOME PREGNANCY TEST | Quidel Corp. | 1995-10-13 | 25 | 0 |
| K950728 | QUICKVUE ONE-STEP ALLERGEN SCREEN | Quidel Corp. | 1995-10-02 | 228 | 0 |
| K953063 | CONCEIVE OVULATION PREDICTOR | Quidel Corp. | 1995-08-23 | 54 | 0 |
| K946276 | QUICKVUE(R) CHLAMYDIA TEST | Quidel Corp. | 1995-05-19 | 147 | 0 |
| K945080 | QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & | Quidel Corp. | 1995-02-10 | 116 | 1 |
| K945969 | RAPIDVUE(TM) HCG | Quidel Corp. | 1995-01-27 | 51 | 0 |
| K934484 | QUICKVUE IN-LINE ONE-STEP STREP A TEST | Quidel Corp. | 1994-07-18 | 307 | 0 |
| K932042 | QUICKVUE ONE-STEP HCG COMBO | Quidel Corp. | 1993-06-29 | 63 | 0 |
| K931761 | QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI) | Quidel Corp. | 1993-06-22 | 75 | 0 |
| K925096 | CONCEIVE ONE-STEP PREGNANCY TEST | Quidel Corp. | 1992-12-28 | 81 | 0 |
| K925435 | QUICKVUE ONE-STEP HCG TEST | Quidel Corp. | 1992-12-03 | 36 | 0 |
| K920160 | LH GEN III SELF-TEST/CONCEIVE | Quidel Corp. | 1992-03-11 | 57 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda