Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Texas Immunology, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
132 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991465 | DRUG STOP | Texas Immunology, Inc. | 1999-12-10 | 227 | 0 |
| K980153 | DRUG CHECK | Texas Immunology, Inc. | 1998-03-27 | 70 | 0 |
| K973208 | FIRST SIGN | Texas Immunology, Inc. | 1997-10-20 | 54 | 0 |
| K972094 | TARGET CARDIAC TROPONIN I TEST | Texas Immunology, Inc. | 1997-07-23 | 49 | 0 |
| K963680 | TARGET MYOGLOBIN TEST | Texas Immunology, Inc. | 1997-02-06 | 143 | 0 |
| K912246 | TARGET MICROALBUMINURIA TEST | Texas Immunology, Inc. | 1991-07-19 | 59 | 0 |
| K910073 | TARGET ASO TEST | Texas Immunology, Inc. | 1991-05-21 | 132 | 0 |
| K904105 | V-TREND TARGET RF TEST | Texas Immunology, Inc. | 1990-10-15 | 39 | 0 |
| K892231 | V-TREND TARGET CRP TEST | Texas Immunology, Inc. | 1989-04-21 | 17 | 0 |
| K890423 | V-TREND TARGET CRP TEST | Texas Immunology, Inc. | 1989-02-17 | 22 | 0 |
| K890041 | V-TREND TARGET IM TEST | Texas Immunology, Inc. | 1989-01-23 | 18 | 0 |
| K880483 | V-TREND STREP A TEST | Texas Immunology, Inc. | 1988-04-12 | 67 | 0 |
| K880399 | V-TREND IM DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-17 | 19 | 0 |
| K875180 | V-TREND RPRL CARD TEST | Texas Immunology, Inc. | 1988-02-04 | 49 | 0 |
| K875262 | V-TREND BETA-HCG DRY-SPOT TEST | Texas Immunology, Inc. | 1988-02-02 | 42 | 0 |
| K874638 | V-TREND BETA-HCG TEST | Texas Immunology, Inc. | 1988-01-21 | 70 | 0 |
| K862817 | V-TREND QC TDM CONTROL SERUM 1,2,3. | Texas Immunology, Inc. | 1986-08-19 | 26 | 0 |
| K861756 | V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II | Texas Immunology, Inc. | 1986-07-07 | 62 | 0 |
| K855220 | V-TREND KIT STAPH LATEX TEST | Texas Immunology, Inc. | 1986-03-03 | 63 | 0 |
| K853857 | V-TREND ASO PLUS LATEX TEST | Texas Immunology, Inc. | 1985-10-16 | 30 | 0 |
| K831597 | SERO/TEX RED CELL RF TEST | Texas Immunology, Inc. | 1983-06-30 | 44 | 0 |
| K822540 | COUNT-10 TROL | Texas Immunology, Inc. | 1982-10-08 | 46 | 0 |
| K821388 | SERO/TEX CRP TEST | Texas Immunology, Inc. | 1982-07-02 | 53 | 0 |
| K821386 | SERO/TEX MONO TEST | Texas Immunology, Inc. | 1982-07-02 | 53 | 0 |
| K821387 | PREG/TEX PREGNANCY TEST | Texas Immunology, Inc. | 1982-06-02 | 23 | 0 |
| K821385 | SERO/TEX LE TEST | Texas Immunology, Inc. | 1982-05-28 | 18 | 0 |
| K821319 | SERO/TEX RF TEST | Texas Immunology, Inc. | 1982-05-21 | 17 | 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