Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sterling Diagnostics, Inc. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
55 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921412 | MICROPROTEIN REAGENT SET | Sterling Diagnostics, Inc. | 1993-01-21 | 303 | 0 |
| K914609 | TRIGLYCERIDES REAGENT SET | Sterling Diagnostics, Inc. | 1991-11-07 | 21 | 0 |
| K914039 | SODIUM REAGENT SET | Sterling Diagnostics, Inc. | 1991-10-31 | 51 | 0 |
| K914040 | PHOSPHOLIPID REAGENT SET | Sterling Diagnostics, Inc. | 1991-10-30 | 50 | 0 |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | Sterling Diagnostics, Inc. | 1986-07-29 | 46 | 0 |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Sterling Diagnostics, Inc. | 1986-07-07 | 48 | 0 |
| K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET | Sterling Diagnostics, Inc. | 1986-07-01 | 18 | 0 |
| K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) | Sterling Diagnostics, Inc. | 1986-07-01 | 21 | 0 |
| K862209 | ALT (SGPT) REAGENT SET (UV RATE) | Sterling Diagnostics, Inc. | 1986-06-25 | 15 | 0 |
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | Sterling Diagnostics, Inc. | 1986-06-16 | 33 | 0 |
| K861615 | SALICYLATE REAGENT SET | Sterling Diagnostics, Inc. | 1986-05-23 | 24 | 0 |
| K861713 | SERUM POTASSIUM REAGENT SET | Sterling Diagnostics, Inc. | 1986-05-23 | 18 | 0 |
| K861311 | GLUCOSE (HEXOKINASE) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-24 | 16 | 0 |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-24 | 84 | 0 |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-04-03 | 52 | 0 |
| K860477 | URIC ACID REAGNET SET (TRINDER) | Sterling Diagnostics, Inc. | 1986-04-03 | 55 | 0 |
| K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-03 | 38 | 0 |
| K860216 | SGOT (AST) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-03 | 71 | 1 |
| K860214 | TOTAL BILIRUBIN REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-17 | 54 | 0 |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-17 | 46 | 0 |
| K860478 | SERUM IRON & IRON BINDING REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-14 | 35 | 1 |
| K860554 | SERUM LIPASE REAGENT SET (TURBIDIMETRIC) | Sterling Diagnostics, Inc. | 1986-03-14 | 28 | 0 |
| K860628 | INORGANIC PHOSPHORUS REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-14 | 23 | 0 |
| K860476 | ACID PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-05 | 26 | 0 |
| K860475 | HEMOGLOBIN REAGENT SET | Sterling Diagnostics, Inc. | 1986-03-03 | 24 | 0 |
| K860349 | LACTATE DEHYDROGENASE (LDH) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-28 | 29 | 0 |
| K860530 | AMYLASE REAGENT SET (MODIFIED CARAWAY) | Sterling Diagnostics, Inc. | 1986-02-28 | 16 | 0 |
| K860420 | SICKLE CELL REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-24 | 20 | 0 |
| K860340 | SERUM ALBUMIN (BCG) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-19 | 21 | 0 |
| K855164 | ENZYNATIC TRIGLYCERIDES REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-19 | 55 | 0 |
| K860419 | UREA NITROGEN REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 7 | 0 |
| K860044 | CALCIUM (CPC) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 36 | 0 |
| K860351 | ALKALINE PHOSPHATASE REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 12 | 0 |
| K860142 | URIC ACID REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-02-11 | 28 | 1 |
| K860215 | MAGNESIUM REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 20 | 0 |
| K860341 | TOTAL PROTEIN (BIURET) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 13 | 0 |
| K860096 | CPK REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-02-11 | 32 | 0 |
| K860418 | CREATININE REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-11 | 7 | 1 |
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-06 | 21 | 1 |
| K855028 | TOTAL CHOLESTEROL REAGENT SET | Sterling Diagnostics, Inc. | 1986-01-28 | 43 | 0 |
| K854335 | GLUCOSE REAGENT SET (GOD/TRINDER) | Sterling Diagnostics, Inc. | 1985-11-22 | 25 | 1 |
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