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510(k) K101335

CELL-CHEX by Streck — Product Code GLQ

K101335 is an FDA 510(k) premarket notification submitted by Streck for the device "CELL-CHEX". The FDA issued a decision of Substantially Equivalent on August 23, 2010. The device falls under product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices), a Class II device regulated under 21 CFR 864.8625. Streck has at least 10 other 510(k) clearances on record.

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

Other clearances by Streck

  • K260041 — MDx-Chex for BCP (March 27, 2026)
  • K254166 — MDx-Chex for BCN (March 23, 2026)
  • K254167 — MDx-Chex for BCY (March 17, 2026)
  • K231776 — Cell-Free DNA BCT (July 26, 2024)
  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K231221 — MDx-Chex for BC-GP (July 27, 2023)
  • 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)

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)

FDA data resources