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510(k) K993825

PARA TECH PLUS RETICS by Streck Laboratories, Inc. — Product Code JCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1999
Date Received
November 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Cell Counter, Normal And Abnormal
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Streck Laboratories, Inc.

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  • 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 JCN

  • K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (June 16, 1994)
  • K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE (December 6, 1993)
  • K911582 — STAK-CHEX (May 28, 1991)
  • K902391 — CELL-DYN 3000 CONTROL (August 22, 1990)
  • K902389 — TRI-COUNT 16 (August 22, 1990)
  • K901875 — PARA 12 PLUS (May 30, 1990)
  • K896154 — PARA TECH FOR TECHNICON H-1 (November 9, 1989)
  • K895373 — HEMATOLOGY CONTROL (October 6, 1989)
  • K891907 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (April 11, 1989)
  • K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (December 30, 1987)