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510(k) K043378

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT by Drew Scientific , Ltd. — Product Code JIT

K043378 is an FDA 510(k) premarket notification submitted by Drew Scientific , Ltd. for the device "DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on December 29, 2004. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Drew Scientific , Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2004
Date Received
December 8, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
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)
  • 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)

Other clearances for product code JIT

  • K171168 — VITROS Immunodiagnostic Products Insulin Calibrators (May 16, 2017)
  • K170938 — CalSet IGF-1 (April 26, 2017)
  • K170160 — Abbott ARCHITECT Free T3 (February 15, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163534 — Lumipulse G FSH-N Calibrators (January 13, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)

FDA data resources