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510(k) K980724

TINAQUANT B 2-MICROGLOBULIN ASSAY by Boehringer Mannheim Corp. — Product Code JZG

K980724 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "TINAQUANT B 2-MICROGLOBULIN ASSAY". The FDA issued a decision of Substantially Equivalent on October 16, 1998. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1998
Date Received
February 24, 1998
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 Boehringer Mannheim Corp.

  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982949 — ELECSYS PSA, MODEL 2010 (October 27, 1998)

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