Atlas FDA

DAKOCYTOMATION ER/PR PHARMDX KIT

FDA 510(k) clearance K042884 · decided 2005-02-15

Clearance details

K-number
K042884
Device name
DAKOCYTOMATION ER/PR PHARMDX KIT
Applicant
Dakocytomation California, Inc.
Decision
Substantially Equivalent
Date received
2004-10-19
Decision date
2005-02-15
Days to decision
119 days
Clearance type
Traditional
Product code
MXZ
Device class
2
Regulation number
864.1860
Medical specialty
Hematology
Advisory committee
Hematology
Location
Carpinteria, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Dakocytomation California

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). (K193393)Leica Biosystems Newcastle, Ltd.2020-03-06
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody (K183102)Leica Biosystems Newcastle, Limited2018-12-07
FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) (K170005)Dako Denmark A/S2017-12-21
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (K171753)Leica Biosystems Newcastle, Limited2017-07-21
FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) (K160922)Dako North America, Inc.2016-05-03
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) (K130861)Dako North America, Inc.2013-12-09
CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY (K103818)Ventana Medical Sytems, Inc.2011-11-16
VISION BIOSYSTEMS PROGESTERONE RECEPTOR PGR CLONE 16 (K062615)Vision Biosystems, Inc.2007-01-29
NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN PROGESTERONE RECEPTOR ANTIBODY (CLONE SP2) (K060462)Lab Vision Corp.2006-04-24
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR (K012960)Biogenex Laboratories2002-03-08
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING (K020023)Dako Corp.2002-02-28
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6) (K990618)Ventana Medical Systems, Inc.1999-07-23

Recalls involving this device

No recalls on record reference this clearance.