Atlas FDA

VENTANA CD30 (Ber-H2) RxDx Assay

FDA 510(k) clearance K172471 · decided 2018-05-08

Clearance details

K-number
K172471
Device name
VENTANA CD30 (Ber-H2) RxDx Assay
Applicant
Ventana Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2017-08-15
Decision date
2018-05-08
Days to decision
266 days
Clearance type
Traditional
Product code
DEH
Device class
2
Regulation number
866.5550
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tucson, AZ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
FREELITE HUMAN LAMBDA FREE KIT (K140396)The Binding Site Group , Ltd.2014-04-16
LAMBDA LIGHT CHAINS (K083601)SENTINEL CH. SpA2009-06-22
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (K033811)The Binding Site, Ltd.2004-01-30
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II (K031016)The Binding Site, Ltd.2003-07-15
FREELITE HUMAN LAMBDA FREE KIT (K023131)The Binding Site, Ltd.2003-01-21
FREELITE LAMBDA FREE KIT (K010440)The Binding Site, Ltd.2001-04-26
FREELITE KAPPA FREE KIT (K010441)The Binding Site, Ltd.2001-04-26
LAMBDA IMMAGE FREELITE KIT (K003671)The Binding Site, Ltd.2001-02-01
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002563)The Binding Site, Ltd.2000-10-26
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING (K971905)Dako Corp.1997-12-12
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) (K965022)Dako Corp.1997-11-06
VENTANA CD45 PRIMARY ANTIBODY (K940583)Ventana Medical Systems, Inc.1997-10-20

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059)Ventana Medical Systems, Inc.2025-12-15
HER2 Dual ISH DNA Probe Cocktail (P190031/S014)Ventana Medical Systems, Inc.2025-12-15
CINtec PLUS Cytology (P190024/S015)Ventana Medical Systems, Inc.2025-09-04
CINtec PLUS Cytology (P190024/S014)Ventana Medical Systems, Inc.2025-07-31
VENTANA CLDN18 (43-14A) RxDx Assay (P230018/S001)Ventana Medical Systems, Inc.2025-06-20
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S057)Ventana Medical Systems, Inc.2025-06-20
VENTANA ALK (D5F3) CDX ASSAY (P140025/S025)Ventana Medical Systems, Inc.2025-06-20
VENTANA PD-L1 (SP263) ASSAY (P160046/S020)Ventana Medical Systems, Inc.2025-06-20