Home / 510(k) Clearances / K012152

510(k) K012152

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

K012152 is an FDA 510(k) premarket notification submitted by Drew Scientific , Ltd. for the device "DS30 HCY BLOOD COLLECTION TUBES". The FDA issued a decision of Substantially Equivalent on September 18, 2001. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Drew Scientific , Ltd. has at least 8 other 510(k) clearances on record.

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

Other clearances by Drew Scientific , Ltd.

  • K071562 — D3 HEMATOLOGY ANALYZER, MODEL D3 (December 11, 2007)
  • 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)
  • 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)

Other clearances for product code GIM

  • K240455 — BD Vacutainer® Citrate Blood Collection Tubes (October 31, 2024)
  • K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blo (November 27, 2023)
  • K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collecti (August 25, 2023)
  • K162723 — TransFix/EDTA Vacuum Blood Collection Tubes (June 22, 2017)
  • K080552 — CYTO-CHEX BCT (July 31, 2008)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K971221 — GREINER VACUETTE BLOOD COLLECTION TUBE (May 2, 1997)
  • K951886 — LOK-ON NEEDLE DISPOSAL SYSTEM (June 30, 1995)
  • K945458 — VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (February 6, 1995)
  • K944814 — CORVAC PLASTIC BLOOD COLLECTION TUBE (December 19, 1994)

FDA data resources