Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anco Medical Reagents & Assoc. · Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
55 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH | Anco Medical Reagents & Assoc. | 1984-07-27 | 36 | 0 |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Anco Medical Reagents & Assoc. | 1983-07-28 | 45 | 0 |
| K821658 | HEMOGLOBIN REAGENT | Anco Medical Reagents & Assoc. | 1982-06-25 | 21 | 0 |
| K821526 | ACID PHOSPHATASE REAGENT SET | Anco Medical Reagents & Assoc. | 1982-06-10 | 20 | 0 |
| K821102 | MEGNESIUM REAGENT KIT | Anco Medical Reagents & Assoc. | 1982-05-05 | 15 | 0 |
| K820951 | ENZYMATIC CHOLESTEROL KIT | Anco Medical Reagents & Assoc. | 1982-04-26 | 20 | 0 |
| K820500 | TOTAL LIPID REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | 16 | 0 |
| K820491 | SGPT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | 16 | 0 |
| K820466 | SGOT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | 17 | 0 |
| K812837 | ALKALINE PHOSPHATASE REAGENT SET | Anco Medical Reagents & Assoc. | 1982-01-29 | 112 | 0 |
| K813415 | UREA NITROGEN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-31 | 24 | 0 |
| K813400 | INORGANIC PHOSPHORUS REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-22 | 18 | 0 |
| K812839 | HDL CHOLESTEROL REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | 55 | 0 |
| K812840 | SERUM IRON REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | 55 | 0 |
| K812834 | CREATININE REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | 55 | 0 |
| K812838 | TRIGLYCERIDE REAGENT SET | Anco Medical Reagents & Assoc. | 1981-12-03 | 55 | 0 |
| K812833 | TOTAL PROTEIN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-11-27 | 49 | 0 |
| K812841 | TOTAL & DIRECT BILIRUBIN REAGENT SET | Anco Medical Reagents & Assoc. | 1981-11-27 | 49 | 0 |
| K812836 | LDH REAGENT SET | Anco Medical Reagents & Assoc. | 1981-10-09 | 0 | 0 |
| K812835 | TOTAL CALCIUM REAGENT SET | Anco Medical Reagents & Assoc. | 1981-10-09 | 0 | 0 |
| K811764 | URIC ACID REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-20 | 59 | 0 |
| K811828 | SICKLE CELL REAGENT SET | Anco Medical Reagents & Assoc. | 1981-08-12 | 44 | 0 |
| K810092 | CHOLESTEROL STANDARD | Anco Medical Reagents & Assoc. | 1981-02-02 | 20 | 0 |
| K810089 | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI | Anco Medical Reagents & Assoc. | 1981-01-26 | 13 | 0 |
| K810091 | GLUCOSE STANDARD | Anco Medical Reagents & Assoc. | 1981-01-26 | 13 | 0 |
| K810090 | CHOLESTEROL REAGENT | Anco Medical Reagents & Assoc. | 1981-01-26 | 13 | 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