Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Advanced Magnetics, Inc. — Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902748SEROZYME FREE T3 IMMUNOASSAYAdvanced Magnetics, Inc.1990-08-09480
K900060FREE T4 IMMUNOASSAY KITAdvanced Magnetics, Inc.1990-03-29850
K894200FREE T3 RADIOIMMUNOASSAY KITAdvanced Magnetics, Inc.1989-09-251010
K884753MODIFIED FREE T4 RADIOIMMUNOASSAY KITAdvanced Magnetics, Inc.1989-02-271050

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