Atlas FDA

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k) clearance K090236 · decided 2009-04-27

Clearance details

K-number
K090236
Device name
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-02-02
Decision date
2009-04-27
Days to decision
84 days
Clearance type
Traditional
Product code
LOJ
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Newark, DE, 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
Elecsys AFP (K220176)Roche Diagnostics2022-09-15
VITROS AFP (K213626)Ortho Clinical Diagnostics2022-06-15
OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709)Olympus Life Science Research Europa GmbH (Europa)2009-03-16
VIDAS AFP ASSAY (K080017)bioMerieux, Inc.2008-09-26
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 (K071597)Dade Behring, Inc.2008-06-04
ST AIA-PACK AFP ENZYME IMMUNOASSAY (K023894)Tosoh Medics, Inc.2002-12-17
AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020807)Bayer Diagnostics Corp.2002-10-01
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (K020806)Bayer Corp.2002-03-27
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (K990138)Diagnostic Systems Laboratories, Inc.1999-06-21
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY (K983031)Ortho-Clinical Diagnostics, Inc.1998-12-18
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 (K983263)Diagnostic Products Corp.1998-12-07
ELECSYS AFP (K981282)Roche Diagnostics GmbH1998-05-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030)Siemens Healthcare Diagnostics2025-07-16
ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24