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510(k) K060083

NRBC-CHEX FOR LH by Streck — Product Code GJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2006
Date Received
January 11, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Red-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)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160585 — XN CAL (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)

Other clearances for product code GJR

  • K080016 — NRBC-CHEX FOR ADVIA (February 5, 2008)
  • K000076 — CELL-CHEX (March 3, 2000)
  • K940430 — SEDRATROL (February 6, 1995)
  • K900484 — RET-CHECK (March 9, 1990)