Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quest Intl., Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
180 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091260 | SERAQUEST EBV EA-D IGG TEST | Quest Intl., Inc. | 2009-06-08 | 40 | 0 |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Quest Intl., Inc. | 2004-01-16 | 29 | 0 |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | Quest Intl., Inc. | 2004-01-15 | 42 | 0 |
| K023593 | SERAQUEST ANTI-THYROID PEROXIDASE (TPO) | Quest Intl., Inc. | 2003-02-06 | 104 | 0 |
| K023592 | SERAQUEST ANTI-THYROGLOBULIN | Quest Intl., Inc. | 2003-01-06 | 73 | 0 |
| K003069 | ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST | Quest Intl., Inc. | 2000-11-27 | 56 | 0 |
| K991975 | SERAQUEST EB NA IGG | Quest Intl., Inc. | 1999-11-02 | 144 | 0 |
| K990410 | SERAQUEST EB VCA IGG | Quest Intl., Inc. | 1999-10-28 | 261 | 0 |
| K990977 | SERAQUEST EB VAC IGM | Quest Intl., Inc. | 1999-10-06 | 197 | 0 |
| K982485 | SERAQUEST CMV IGM | Quest Intl., Inc. | 1999-01-13 | 180 | 2 |
| K982281 | SERAQUEST RUBELLA IGM | Quest Intl., Inc. | 1998-10-16 | 108 | 0 |
| K980540 | SERAQUEST ANTI-SM | Quest Intl., Inc. | 1998-06-15 | 123 | 0 |
| K980639 | SERAQUEST ANTI-SSB | Quest Intl., Inc. | 1998-06-15 | 116 | 0 |
| K980810 | SERAQUEST ANTI-SSA | Quest Intl., Inc. | 1998-05-12 | 70 | 0 |
| K980811 | SERAQUEST ANTI-SM/RNP | Quest Intl., Inc. | 1998-05-12 | 70 | 0 |
| K980391 | SERAQUEST ANTI-DSDNA | Quest Intl., Inc. | 1998-04-24 | 81 | 0 |
| K980059 | SERAQUEST MUMPS IGG | Quest Intl., Inc. | 1998-04-23 | 106 | 0 |
| K972295 | SERAQUEST VZV IGG | Quest Intl., Inc. | 1997-11-05 | 139 | 0 |
| K971672 | SERAQUEST TOXOPLASMA IGM | Quest Intl., Inc. | 1997-10-21 | 167 | 0 |
| K963282 | SERAQUEST HSV IGG | Quest Intl., Inc. | 1997-01-22 | 154 | 0 |
| K961053 | SERAQUEST RUBELLA IGG | Quest Intl., Inc. | 1996-09-04 | 170 | 2 |
| K960092 | SERAQUEST TOXOPLASMA IGG | Quest Intl., Inc. | 1996-06-17 | 158 | 0 |
| K954191 | SERAQUEST CMV IGG | Quest Intl., Inc. | 1996-02-23 | 170 | 0 |
| K891736 | PATIENT EXAMINATION GLOVES (LATEX) | Quest Intl., Inc. | 1989-05-25 | 64 | 0 |
| K890356 | LATEX EXAMINATION GLOVES NON-STERILE | Quest Intl., Inc. | 1989-04-06 | 72 | 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