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510(k) K083926

CD4 COUNT by Streck — Product Code GGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2009
Date Received
December 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, White-Cell
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • DEN200001 — Cell-Free DNA BCT (August 7, 2020)
  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160585 — XN CAL (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)

Other clearances for product code GGL

  • K051633 — CD-CHEX PLUS BC (August 16, 2005)
  • K993126 — CD-CHEX CD 34 (November 26, 1999)
  • K960894 — CD-CHEX + RBC (May 24, 1996)
  • K931825 — CD-CHEX CD4 LOW (June 6, 1994)
  • K920997 — CD-CHEX (May 31, 1992)
  • K894651 — COULTER POSITIVE CONTROL CELLS (September 13, 1989)
  • K891175 — EDL ABNORMAL COAGULATION CONTROL (April 10, 1989)