Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Theratest Laboratories, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
238 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090753 | THERATEST EL-ANTI-CCP/2 | Theratest Laboratories, Inc. | 2010-03-05 | 350 | 0 |
| K090760 | THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, M | Theratest Laboratories, Inc. | 2009-09-03 | 164 | 0 |
| K071692 | THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST | Theratest Laboratories, Inc. | 2007-11-05 | 138 | 0 |
| K061376 | EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 | Theratest Laboratories, Inc. | 2006-07-20 | 64 | 0 |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | Theratest Laboratories, Inc. | 2006-02-07 | 15 | 1 |
| K051066 | THERATEST EL-ANA PROFILES | Theratest Laboratories, Inc. | 2005-10-07 | 164 | 0 |
| K040291 | EL-ANA PROFILES: ANTI-CHROMATIN | Theratest Laboratories, Inc. | 2004-03-11 | 34 | 0 |
| K024151 | EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P | Theratest Laboratories, Inc. | 2003-02-06 | 62 | 0 |
| K024031 | THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE | Theratest Laboratories, Inc. | 2003-02-06 | 62 | 0 |
| K002559 | EL-ANA PROFILES-2K1 | Theratest Laboratories, Inc. | 2000-09-12 | 26 | 0 |
| K982150 | EL-ANA PROFILES: EL-ENA/4 | Theratest Laboratories, Inc. | 1998-08-13 | 56 | 0 |
| K982622 | EL-ANA PROFILES: EL-ENA/5 | Theratest Laboratories, Inc. | 1998-08-13 | 56 | 0 |
| K972790 | THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR | Theratest Laboratories, Inc. | 1997-12-05 | 130 | 0 |
| K973882 | EL-B2GP1SCR | Theratest Laboratories, Inc. | 1997-12-05 | 52 | 0 |
| K962050 | THERATEST EL-RFSCR | Theratest Laboratories, Inc. | 1996-12-16 | 202 | 0 |
| K955481 | THERATEST KIT (MODIFICATION) | Theratest Laboratories, Inc. | 1996-03-06 | 112 | 0 |
| K954106 | THERATEST LAB, INC., EL-ANASCR KIT | Theratest Laboratories, Inc. | 1995-11-14 | 105 | 0 |
| K950716 | THERATEST EL-ANA PROFILES TEST SYSTEM | Theratest Laboratories, Inc. | 1995-09-26 | 238 | 0 |
| K941398 | EL-RF/3 (IGM-IGG-IGA) KIT | Theratest Laboratories, Inc. | 1995-07-28 | 493 | 1 |
| K933712 | EL-RF TEST SYSTEM: EL-RF-IGM KIT | Theratest Laboratories, Inc. | 1994-01-28 | 182 | 0 |
| K914454 | THE THERATEST EL-ANA PROFILES | Theratest Laboratories, Inc. | 1992-05-22 | 228 | 0 |
| K905301 | THE THERATEST ACA TEST | Theratest Laboratories, Inc. | 1991-01-14 | 48 | 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