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510(k) K901333

BETA-2 MICROGLOBULIN EIA by Serex, Inc. — Product Code JZG

K901333 is an FDA 510(k) premarket notification submitted by Serex, Inc. for the device "BETA-2 MICROGLOBULIN EIA". The FDA issued a decision of Substantially Equivalent on April 2, 1990. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Serex, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1990
Date Received
March 20, 1990
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

Other clearances by Serex, Inc.

  • K923314 — AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (August 24, 1992)
  • K921834 — AUTOMATES COMA COCAINE METABOLITE ASSAY (June 15, 1992)
  • K895043 — COMA COCAINE METABOLITE ASSAY (EIA) (November 8, 1989)
  • K890694 — BETA-2 MICROGLOBULIN EIA (March 16, 1989)

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)
  • K083463 — DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIME (March 13, 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)

FDA data resources