Atlas FDA

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

MXZ — Predicate Candidate Screening

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

119 daysmedian FDA review time
322 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K193393BOND Ready-to-Use Primary Antibody Progesterone Receptor (16Leica Biosystems Newcastle, Ltd.2020-03-06910
K183102BOND Ready-to-Use (RTU) Primary Antibody Progesterone ReceptLeica Biosystems Newcastle, Limited2018-12-07300
K170005FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, ClonDako Denmark A/S2017-12-213520
K171753BOND Ready-to-Use (RTU) Primary Antibody Progesterone ReceptLeica Biosystems Newcastle, Limited2017-07-21390
K160922FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, ClonDako North America, Inc.2016-05-03290
K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGRDako North America, Inc.2013-12-092560
K103818CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PVentana Medical Sytems, Inc.2011-11-163221
K062615VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16Vision Biosystems, Inc.2007-01-291460
K060462NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOLab Vision Corp.2006-04-24610
K042884DAKOCYTOMATION ER/PR PHARMDX KITDakocytomation California, Inc.2005-02-151190
K012960BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTORBiogenex Laboratories2002-03-081850
K020023DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONDako Corp.2002-02-28560
K990618VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)Ventana Medical Systems, Inc.1999-07-231482

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