Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sandare Chemical Co., Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
65 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | Sandare Chemical Co., Inc. | 1987-09-29 | 71 | 0 |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Sandare Chemical Co., Inc. | 1986-08-08 | 36 | 0 |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | Sandare Chemical Co., Inc. | 1986-03-17 | 20 | 0 |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | Sandare Chemical Co., Inc. | 1985-05-07 | 28 | 0 |
| K851394 | SANDARE IRON PROCEDURE | Sandare Chemical Co., Inc. | 1985-04-30 | 21 | 0 |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Sandare Chemical Co., Inc. | 1984-12-10 | 20 | 0 |
| K842516 | SANDARE ACID PHOSPHATASE PROCEDURE | Sandare Chemical Co., Inc. | 1984-08-17 | 38 | 0 |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | Sandare Chemical Co., Inc. | 1984-01-13 | 60 | 0 |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | Sandare Chemical Co., Inc. | 1983-11-07 | 69 | 0 |
| K832632 | ALBUMIN PROCEDURE BCP | Sandare Chemical Co., Inc. | 1983-09-12 | 39 | 0 |
| K832183 | SANDARE CALCIUM PROCEDURE | Sandare Chemical Co., Inc. | 1983-08-24 | 49 | 0 |
| K832169 | TOTAL PROTEIN PROCEDURE | Sandare Chemical Co., Inc. | 1983-08-16 | 41 | 0 |
| K812670 | SANDARE FAST 340 PHOSPHORUS PROCEDURE | Sandare Chemical Co., Inc. | 1981-10-02 | 11 | 0 |
| K812313 | SANDARE URIC ACID PROCEDURE | Sandare Chemical Co., Inc. | 1981-09-01 | 15 | 0 |
| K810514 | SANDARE NITROPRUSSIDE TEST PROCEDURE | Sandare Chemical Co., Inc. | 1981-03-04 | 7 | 0 |
| K802832 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Sandare Chemical Co., Inc. | 1981-01-16 | 65 | 0 |
| K801422 | SANDARE LYOPHILIZED GLYCOHEMOGLOBIN CLS. | Sandare Chemical Co., Inc. | 1980-07-08 | 21 | 0 |
| K800780 | SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS | Sandare Chemical Co., Inc. | 1980-04-24 | 16 | 0 |
| K800297 | SANDARE FAST 340 PHOSPHOROUS PROCEDURE | Sandare Chemical Co., Inc. | 1980-03-05 | 23 | 0 |
| K792531 | SANDARE CHLORIDE PROCEDURE | Sandare Chemical Co., Inc. | 1980-01-11 | 35 | 0 |
| K792358 | SANDARE CYANMETHEMOGLOBIN STANDARD | Sandare Chemical Co., Inc. | 1979-12-31 | 40 | 0 |
| K792503 | SANDARE CYANMETHEMOGLOBIN REAGENT | Sandare Chemical Co., Inc. | 1979-12-31 | 27 | 0 |
| K792209 | SANDARE HEMOGLOBIN CONTROLS | Sandare Chemical Co., Inc. | 1979-12-04 | 32 | 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