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510(k) K091711

S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 by Alfa Wassermann Diagnostic Technologies, Inc. — Product Code LCP

K091711 is an FDA 510(k) premarket notification submitted by Alfa Wassermann Diagnostic Technologies, Inc. for the device "S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023". The FDA issued a decision of Substantially Equivalent on December 11, 2009. The device falls under product code LCP (Assay, Glycosylated Hemoglobin), a Class II device regulated under 21 CFR 864.7470. Alfa Wassermann Diagnostic Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2009
Date Received
June 10, 2009
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 Alfa Wassermann Diagnostic Technologies, Inc.

  • K170623 — ACE Hemoglobin A1c (HbA1c) Reagent (February 27, 2018)
  • K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, A (October 2, 2013)
  • K131351 — ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (August 15, 2013)
  • K123953 — ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REA (May 2, 2013)
  • K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELEC (April 23, 2013)
  • K122757 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES (October 5, 2012)
  • K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (August 10, 2012)
  • K113437 — ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, A (August 6, 2012)
  • K113374 — ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE P (July 13, 2012)
  • K113262 — ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERID (July 3, 2012)

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