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510(k) K993375

CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER by Clinical Diagnostic Solutions, Inc. — Product Code KRX

K993375 is an FDA 510(k) premarket notification submitted by Clinical Diagnostic Solutions, Inc. for the device "CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER". The FDA issued a decision of Substantially Equivalent on December 20, 1999. The device falls under product code KRX (Calibrator For Cell Indices), a Class II device regulated under 21 CFR 864.8150. Clinical Diagnostic Solutions, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1999
Date Received
October 7, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Cell Indices
Device Class
Class II
Regulation Number
864.8150
Review Panel
HE
Submission Type

Other clearances by Clinical Diagnostic Solutions, Inc.

  • K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL) (June 10, 2004)
  • K024173 — CDS 3-PD HEMATOLOGY CONTROLS (January 14, 2003)

Other clearances for product code KRX

  • K160585 — XN CAL (December 22, 2016)
  • K141962 — XN CAL (December 5, 2014)
  • K141955 — XN CAL PF (December 5, 2014)
  • K120747 — XN CAL PF (October 22, 2012)
  • K120745 — XN CAL (October 19, 2012)
  • K111204 — CELL-DYN 22 PLUS CALIBRATOR (December 22, 2011)
  • K083200 — X-CAL (February 3, 2009)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K003991 — CD-CAL PLUS CALIBRATOR (January 16, 2001)
  • K955925 — CBC-CAL PLUS HEMATOLOGY CALIBRATOR (February 29, 1996)

FDA data resources