Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eppendorf-Brinkmann, 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) |
|---|---|---|---|---|---|
| K780819 | GLYCOHEMOGLOBIN-SKREEN TEST KIT | Eppendorf-Brinkmann, Inc. | 1978-11-07 | 174 | 0 |
| K772337 | URINARY 17-KETOSTERIOD/17 | Eppendorf-Brinkmann, Inc. | 1978-01-12 | 21 | 0 |
| K772151 | URINARY VMA - SCREEN TEST KIT | Eppendorf-Brinkmann, Inc. | 1977-11-30 | 15 | 0 |
| K761271 | URIN. L7-OH CORTICOSTEROID T(NON HYDRO) | Eppendorf-Brinkmann, Inc. | 1977-02-14 | 56 | 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