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510(k) K021922

MODIFICATION TO PARA 5X by Streck Laboratories, Inc. — Product Code JPK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2002
Date Received
June 11, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
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)
  • 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)
  • K000115 — RETIC CHEX LINEARITY (March 27, 2000)

Other clearances for product code JPK

  • K160590 — XN CHECK (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K120742 — XN CHECK (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)