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510(k) K831053

QUANTIGEN T & B CELL ASSAY by Bio-Rad — Product Code LIZ

K831053 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "QUANTIGEN T & B CELL ASSAY". The FDA issued a decision of Substantially Equivalent on August 8, 1983. The device falls under product code LIZ (Assay, T Lymphocyte Surface Marker), a Class II device regulated under 21 CFR 864.5220. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1983
Date Received
April 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, T Lymphocyte Surface Marker
Device Class
Class II
Regulation Number
864.5220
Review Panel
IM
Submission Type

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

Other clearances for product code LIZ

  • K914847 — CD8 MONOCLONAL ANTIBODIES (June 19, 1992)
  • K860830 — TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD (September 8, 1986)
  • K843062 — TBM-REAGENT FOR T,B CELL & MONOCYTES (April 3, 1985)
  • K842218 — ANTI-LEU-4 FITC LYSIN C BUFFER (December 27, 1984)
  • K833929 — WHITE BLOOD CELLS HUMAN TAND B (February 3, 1984)
  • K820643 — ORTHO SPECTRUM III & ORTHO-MUNE OK (July 14, 1982)

FDA data resources