Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
U. S. Diagnostics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
218 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | U. S. Diagnostics, Inc. | 2011-09-21 | 218 | 0 |
| K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, | U. S. Diagnostics, Inc. | 2009-02-20 | 199 | 0 |
| K061431 | EASYGLUCO, MODEL IGM-0002 G2 | U. S. Diagnostics, Inc. | 2007-01-12 | 233 | 0 |
| K051651 | G4, MODEL IGM-0004 | U. S. Diagnostics, Inc. | 2006-04-14 | 297 | 0 |
| K870596 | PROTHROMBIN TIME TEST | U. S. Diagnostics, Inc. | 1987-04-20 | 69 | 0 |
| K870687 | COAGULATION CONTROL, LEVEL III | U. S. Diagnostics, Inc. | 1987-04-20 | 60 | 0 |
| K870685 | COAGULATION CONTROL, LEVEL I | U. S. Diagnostics, Inc. | 1987-04-20 | 60 | 0 |
| K870686 | COAGULATION CONTROL, LEVEL II | U. S. Diagnostics, Inc. | 1987-04-20 | 60 | 0 |
| K871283 | CYANMETHEMOGLOBIN STANDARD | U. S. Diagnostics, Inc. | 1987-04-15 | 15 | 0 |
| K870737 | U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL | U. S. Diagnostics, Inc. | 1987-04-13 | 47 | 0 |
| K870738 | U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL | U. S. Diagnostics, Inc. | 1987-04-13 | 47 | 0 |
| K870684 | LIQUID CHEMISTRY CONTROL, LEVEL I | U. S. Diagnostics, Inc. | 1987-04-06 | 46 | 0 |
| K870683 | LIQUID CHEMISTRY CONTROL, LEVEL II | U. S. Diagnostics, Inc. | 1987-04-06 | 46 | 0 |
| K870688 | O.O2 M CALCIUM CHLORIDE SOLUTION | U. S. Diagnostics, Inc. | 1987-03-31 | 40 | 0 |
| K864231 | U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST | U. S. Diagnostics, Inc. | 1986-12-04 | 37 | 0 |
| K864081 | U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST | U. S. Diagnostics, Inc. | 1986-12-04 | 45 | 0 |
| K863980 | U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST | U. S. Diagnostics, Inc. | 1986-12-04 | 51 | 0 |
| K863889 | UREA NITROGEN TEST | U. S. Diagnostics, Inc. | 1986-11-24 | 49 | 0 |
| K864119 | URIC ACID TEST | U. S. Diagnostics, Inc. | 1986-10-29 | 8 | 0 |
| K862669 | ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | U. S. Diagnostics, Inc. | 1986-10-03 | 81 | 0 |
| K862721 | ENZYMATIC BLOOD GLUCOSE | U. S. Diagnostics, Inc. | 1986-09-03 | 48 | 0 |
| K862641 | U.S. DIAGNOSTIC INC. HEMOGLOBIN TEST (DRY PACK) | U. S. Diagnostics, Inc. | 1986-08-21 | 41 | 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