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510(k) K083463

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M by Siemens Healthcare Diagnostics — Product Code JZG

K083463 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M". The FDA issued a decision of Substantially Equivalent on March 13, 2009. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2009
Date Received
November 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Beta-2-Microglobulin Immunological
Device Class
Class II
Regulation Number
866.5630
Review Panel
IM
Submission Type

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Other clearances for product code JZG

  • K161297 — Beta-2-Microglobulin (June 7, 2016)
  • K122066 — HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS (August 30, 2012)
  • K110874 — ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR (January 20, 2012)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K072078 — QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307 (December 19, 2007)
  • K063272 — DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDI (January 26, 2007)
  • K050613 — QUANTIA BETA-2 MICROGLOBULIN (August 16, 2005)
  • K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (January 22, 2004)
  • K014270 — MININEPH HUMAN B2-MICROGLOBULIN KIT (August 15, 2002)
  • K002731 — N LATEX B2-MICROGLOBULIN (November 20, 2000)

FDA data resources