GLYCOSYLATED HEMOGLOBIN KIT— 510(k) K801561

Substantially Equivalent

Amersham Corp.

FDA 510(k) clearance K801561 for GLYCOSYLATED HEMOGLOBIN KIT, Substantially Equivalent on 1980-08-12. Applicant: Amersham Corp.. Device class: 2.

Clearance details

Applicant: Amersham Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 1980-07-08
Decision date: 1980-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCP

K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer2024-11-22
K231465 — Q-Pad Test System2023-12-06
K214117 — Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer2023-09-27
K192987 — Aina HbA1c Monitoring System 22020-03-26
K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit2019-10-29

More clearances from Amersham Corp.

K914135 — AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/20861992-02-18
K912733 — AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT1991-07-22
K912766 — AMERLITE CK-MB ASSAY1991-07-17
K904666 — AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/20081990-11-02
K902760 — AMERSHAM TSH CONTROL SERA1990-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.