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510(k) K051200

HEMOGLOBIN A1C REAGENT SET by Teco Diagnostics — Product Code LCP

K051200 is an FDA 510(k) premarket notification submitted by Teco Diagnostics for the device "HEMOGLOBIN A1C REAGENT SET". The FDA issued a decision of Substantially Equivalent on August 8, 2005. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Teco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2005
Date Received
May 10, 2005
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 Teco Diagnostics

  • K170118 — Scanostics UTI Check Application Test System (September 21, 2017)
  • K161527 — Teco Creatinine Enzymatic Reagent Kit (July 21, 2017)
  • K170200 — Carbon Dioxide Reagent Set (June 1, 2017)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (March 7, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
  • K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS (May 29, 2014)
  • K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST (October 4, 2011)
  • K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS (February 17, 2011)
  • K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 (February 4, 2011)

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