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510(k) K101335

CELL-CHEX by Streck — Product Code GLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2010
Date Received
May 12, 2010
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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  • K160588 — XN CHECK BF (December 22, 2016)
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Other clearances for product code GLQ

  • K111211 — CELL-DYN 22 PLUS CONTROL (December 22, 2011)
  • K110718 — CELL-CHEX WITH CPPD CRYSTALS (May 26, 2011)
  • 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)