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510(k) K922704

COULTER MAXM W/ AUTOLOADER by Coulter Electronics, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1992
Date Received
June 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

Other clearances by Coulter Electronics, Inc.

  • K923951 — CD8 CYTOSPHERES KIT (April 25, 1994)
  • K930119 — COULTER RETIC-C CELL CONTROL (April 5, 1993)
  • K921279 — CD4 CYTOSPHERES KIT (December 29, 1992)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K922181 — COULTER MH009 (August 17, 1992)
  • K921567 — COULTER MH017 (July 6, 1992)
  • K912133 — PX COULTER(R) CELL CONTROL (July 17, 1991)
  • K911385 — COULTER(R) MH010 (June 17, 1991)
  • K905771 — COULTER DART AST (GOT) REAGENT (February 26, 1991)
  • K905767 — COULTER DART ALT (GPT) REAGENT (January 25, 1991)

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