Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ind Diagnostic, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
551 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | Ind Diagnostic, Inc. | 2012-04-17 | 551 | 1 |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Ind Diagnostic, Inc. | 2010-07-19 | 194 | 0 |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | Ind Diagnostic, Inc. | 2007-03-01 | 112 | 0 |
| K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC | Ind Diagnostic, Inc. | 2006-08-07 | 136 | 0 |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | Ind Diagnostic, Inc. | 2005-12-16 | 79 | 0 |
| K052662 | ONE STEP FSH MENOPAUSAL TEST | Ind Diagnostic, Inc. | 2005-11-30 | 64 | 1 |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | Ind Diagnostic, Inc. | 2005-05-16 | 56 | 3 |
| K023638 | CASSETTE/URINE HCG | Ind Diagnostic, Inc. | 2003-01-03 | 65 | 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