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510(k) K931825

CD-CHEX CD4 LOW by Streck Laboratories, Inc. — Product Code GGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1994
Date Received
April 6, 1993
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

Other clearances by Streck Laboratories, Inc.

  • K042587 — RETIC-CHEX FOR CELL-DYN (October 19, 2004)
  • K040107 — CYTO-CHEX BCT (July 27, 2004)
  • K040025 — A1C-CELLULAR (March 2, 2004)
  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K021922 — MODIFICATION TO PARA 5X (June 25, 2002)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K011410 — PARA 5X (June 26, 2001)
  • K001443 — SUGAR CHEX ONE (June 29, 2000)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)

Other clearances for product code GGL

  • K083926 — CD4 COUNT (February 11, 2009)
  • K051633 — CD-CHEX PLUS BC (August 16, 2005)
  • K993126 — CD-CHEX CD 34 (November 26, 1999)
  • K960894 — CD-CHEX + RBC (May 24, 1996)
  • K920997 — CD-CHEX (May 31, 1992)
  • K894651 — COULTER POSITIVE CONTROL CELLS (September 13, 1989)
  • K891175 — EDL ABNORMAL COAGULATION CONTROL (April 10, 1989)