Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Biological Technologies, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K091460 | ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120 | American Biological Technologies, Inc. | 2009-08-06 | 80 | 0 |
| K090943 | ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089 | American Biological Technologies, Inc. | 2009-05-27 | 54 | 0 |
| K090854 | ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 | American Biological Technologies, Inc. | 2009-04-16 | 17 | 0 |
| K083549 | ABT GLUCOSE CONTROL SOLUTION | American Biological Technologies, Inc. | 2008-12-22 | 21 | 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