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510(k) K111211

CELL-DYN 22 PLUS CONTROL by Streck — Product Code GLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2011
Date Received
April 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K160586 — XN-L CHECK (December 22, 2016)
  • K160585 — XN CAL (December 22, 2016)
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Other clearances for product code GLQ

  • K110718 — CELL-CHEX WITH CPPD CRYSTALS (May 26, 2011)
  • K101335 — CELL-CHEX (August 23, 2010)
  • K090137 — STAK-CHEX PLUS RETICS (March 18, 2009)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)
  • K994388 — XE CHECK (January 14, 2000)
  • K992887 — STAK-CHEX PLUS RETICS (November 22, 1999)
  • K823794 — CONTROL TM 8 (January 14, 1983)
  • K823587 — UNI-CELL (January 5, 1983)
  • K823498 — PARA 12 (December 28, 1982)