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510(k) K020469

CAL-CHEX CD PLUS by Streck Laboratories, Inc. — Product Code KRX

K020469 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "CAL-CHEX CD PLUS". The FDA issued a decision of Substantially Equivalent on April 4, 2002. The device falls under product code KRX (Calibrator For Cell Indices), a Class II device regulated under 21 CFR 864.8150. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2002
Date Received
February 12, 2002
Clearance Type
Traditional
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 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)
  • 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)
  • K000115 — RETIC CHEX LINEARITY (March 27, 2000)

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)
  • K003991 — CD-CAL PLUS CALIBRATOR (January 16, 2001)
  • K993375 — CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER (December 20, 1999)
  • K955925 — CBC-CAL PLUS HEMATOLOGY CALIBRATOR (February 29, 1996)

FDA data resources