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510(k) K955596

N LATEX B2-MICROGLOBULIN REAGENT by Behring Diagnostics, Inc. — Product Code JZG

K955596 is an FDA 510(k) premarket notification submitted by Behring Diagnostics, Inc. for the device "N LATEX B2-MICROGLOBULIN REAGENT". The FDA issued a decision of Substantially Equivalent on October 3, 1996. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Behring Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1996
Date Received
December 8, 1995
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 Behring Diagnostics, Inc.

  • K973832 — OPUS HLH CONTROLS (October 27, 1997)
  • K972929 — N ANTISERUM TO HUMAN ALBUMIN (October 20, 1997)
  • K972840 — N ANTISERUM TO HUMAN TRANSFERRIN (October 17, 1997)
  • K973202 — MODIFICATION OF OPUS FERRITIN TEST SYSTEM (September 12, 1997)
  • K972316 — OPUS D-DIMER (September 9, 1997)
  • K972116 — VON WILLEBRAND REAGENT (July 25, 1997)
  • K972011 — OPUS ETHANOL (July 22, 1997)
  • K971596 — EMIT II OPIATES 300/2000 ASSAY (June 25, 1997)
  • K971600 — EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) (June 25, 1997)
  • K964595 — OPUS PSA TEST SYSTEM (June 24, 1997)

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