Atlas FDA

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

FDA 510(k) clearance K083463 · decided 2009-03-13

Clearance details

K-number
K083463
Device name
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-11-24
Decision date
2009-03-13
Days to decision
109 days
Clearance type
Traditional
Product code
JZG
Device class
2
Regulation number
866.5630
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
Beta-2-Microglobulin (K161297)Beckman Coulter Ireland, Inc.2016-06-07
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QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (K072078)Biokit, S.A.2007-12-19
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH (K063272)Dade Behring, Inc.2007-01-26
QUANTIA BETA-2 MICROGLOBULIN (K050613)Biokit, S.A.2005-08-16
DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (K032692)Dako A/S2004-01-22
MININEPH HUMAN B2-MICROGLOBULIN KIT (K014270)The Binding Site, Ltd.2002-08-15
N LATEX B2-MICROGLOBULIN (K002731)Dade Behring, Inc.2000-11-20
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ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS) (K993711)Bayer Corp.1999-12-16

Recalls involving this device

RecordFirmDate
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalo recall (Z-1030-2016)Siemens Healthcare Diagnostics, Inc.2016-03-01
Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC recall (Z-2450-2015)Siemens Healthcare Diagnostics, Inc.2015-08-22

PMA approvals by this applicant

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Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
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Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24