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510(k) K012152

DS30 HCY BLOOD COLLECTION TUBES by Drew Scientific , Ltd. — Product Code GIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2001
Date Received
July 11, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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  • K043378 — DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT (December 29, 2004)
  • 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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