Home / 510(k) Clearances / K933287

510(k) K933287

745 GLYCOMAT by Drew Scientific , Ltd. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1993
Date Received
July 6, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
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)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K982003 — DS30 HCY HOMOCYSTEINE ASSAY KIT (February 11, 1999)
  • K924496 — GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (November 16, 1992)
  • K920198 — GLYCOMAT HAEMOGLOBIN ANALYSER (July 21, 1992)

Other clearances for product code LCP

  • K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (November 22, 2024)
  • K231465 — Q-Pad Test System (December 6, 2023)
  • K214117 — Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (September 27, 2023)
  • K192987 — Aina HbA1c Monitoring System 2 (March 26, 2020)
  • K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (October 29, 2019)
  • K183230 — OneDraw A1C Test System (August 15, 2019)
  • K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (April 12, 2019)
  • K180509 — Quo-Test A1c System (February 16, 2019)
  • K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c (September 25, 2018)
  • K170623 — ACE Hemoglobin A1c (HbA1c) Reagent (February 27, 2018)