Atlas FDA

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

General Atomics — Predicate Candidate Screening

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

138 daysmedian FDA review time
268 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K082488DIAZYME LP(A) ASSAYGeneral Atomics2009-01-131380
K072977DIAZYME APOLIPOPROTEIN A-1 ASSAYGeneral Atomics2008-07-162680
K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSGeneral Atomics2008-01-221370
K050178HBA1C ENZYMATIC ASSAYGeneral Atomics2005-06-281530
K042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KITGeneral Atomics2004-10-29500
K033360DIAZYME LITHIUM ENZYMATIC ASSAY KITGeneral Atomics2003-12-23630

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