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510(k) K071562

D3 HEMATOLOGY ANALYZER, MODEL D3 by Drew Scientific, Inc. — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2007
Date Received
June 7, 2007
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 Drew Scientific, Inc.

  • K070704 — TRILOGY ANALYZER (July 13, 2007)
  • K060510 — DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT (June 19, 2006)
  • K043378 — DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT (December 29, 2004)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K982003 — DS30 HCY HOMOCYSTEINE ASSAY KIT (February 11, 1999)
  • K933287 — 745 GLYCOMAT (September 9, 1993)
  • K924496 — GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (November 16, 1992)
  • K920198 — GLYCOMAT HAEMOGLOBIN ANALYSER (July 21, 1992)

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