Atlas FDA

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

DFZ — Predicate Candidate Screening

9 FDA 510(k) clearances under this product code; the 50 most recent screened below.

75 daysmedian FDA review time
128 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092283DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CSiemens Healthcare Diagnostics2009-10-21840
K021081HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHThe Binding Site, Ltd.2002-06-17750
K020823PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KITSanquin Blood Supply Foundation2002-05-14610
K955906BOEHRINGER MANNHEIM IGG ASSAYBoehringer Mannheim Corp.1996-02-09420
K940422IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THEThe Binding Site, Ltd.1994-05-271280
K812821H-103 IGG, H-104 IGA, H-105 IGMImmulok, Inc.1981-10-26190
K803272AUTOMATED IMMUNOPRECIPITIN METHOD/ICGIcl Scientific1981-01-26280
K790720ANTISERA TO RABBIT IMMUNOGLOBULINKent Laboratories, Inc.1979-08-161260
K790709ANTISERUM TO RABBIT IMMUNOGLOBULINKent Laboratories, Inc.1979-08-161260

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