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510(k) K012525

THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235 by Thermo Dma, Inc. — Product Code LCP

K012525 is an FDA 510(k) premarket notification submitted by Thermo Dma, Inc. for the device "THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235". The FDA issued a decision of Substantially Equivalent on October 4, 2001. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Thermo Dma, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2001
Date Received
August 6, 2001
Clearance Type
Abbreviated
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 Thermo Dma, Inc.

  • K022108 — THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050 (July 25, 2002)
  • K012878 — THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 (October 16, 2001)
  • K012518 — TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 (October 9, 2001)

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)

FDA data resources