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

Diagnostica, Inc. · Predicate Candidate Screening

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

99 daysmedian FDA review time
140 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002756EASE-A-CULTDiagnostica, Inc.2001-02-231710
K823348H. INFLUENZA B ANTISERA FOR CIEDiagnostica, Inc.1982-12-28490
K812434DIAGNOSTIC KITS & KIT COMPONENTSDiagnostica, Inc.1981-09-23290
K800398PARACONTROL ABNORMAL IMMUNOGLOBULIN CONTDiagnostica, Inc.1980-03-12150
K791283ANTI-HUMAN LAMBDA SERUMDiagnostica, Inc.1979-11-271400
K791281ANTI-HUMAN IGG SERUMDiagnostica, Inc.1979-11-271400
K791284ANTI-HUMAN KAPPA SERUMDiagnostica, Inc.1979-11-271400
K791285ANTI-HUMAN GLOBULINSDiagnostica, Inc.1979-10-17990
K791282ANTI-HUMAN SERUMDiagnostica, Inc.1979-10-17990
K790672ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVUDiagnostica, Inc.1979-05-31550
K790671DERMATOPHYTIN ODiagnostica, Inc.1979-05-31550
K781710BUFFER, COLLAGEN REAGENT AND DILUENTDiagnostica, Inc.1978-10-24190

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