LCP

Product Code: LCP


Products Classified as LCP

2411Assay, Glycosylated HemoglobinGlycosylated Hemoglobin Assay.

Total Product Life Cycle (TPLC) Devices

2411Assay, Glycosylated HemoglobinGlycosylated Hemoglobin Assay.

FDA Consensus Standards

Assay, Glycosylated Hemoglobin [25088]21 CFR §864.7470 🔎

Pre-market Notifications for LCP

K192987Aina HbA1c Monitoring System 2Jana Care, Inc
K192369PixoTest POCT System - PixoTest POCT Analyzer And PixoTest A1c Test KitIXensor Co. Ltd.
K183230OneDraw A1C Test SystemDrawbridge Health, Inc.
K181915PixoTest POCT System - PixoTest POCT Analyzer And PixoTest A1c Test KitIXensor Co., LTD.
K180509Quo-Test A1c SystemEKF-diagnostic GmbH
K173127Skyla Hi Hemoglobin A1c System (skyla Hi Analyzer And Skyla Hi Hemoglobin A 1 C Reagent Kit)Skyla Corporation H.S.P.B.
K171650Alere Afinion HbA1c And ACR On Afinion 2 AnalyzerAbbott Rapid Diagnostics
K170623ACE Hemoglobin A1c (HbA1c) ReagentALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
K170147Lucica Glycated Albumin-LASAHI KASEI PHARMA CORPORATION
K163633Cobas HbA1c Test, Cobas B 101 SystemRoche Diagnostics Operations
K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)SEBIA
K161533A1C EZ Glycohemoglobin Analysis SystemBioHermes Co., Ltd
K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDIAZYME LABORATORIES
K151809Alere Afinion HbA1c, Alere Afinion AS100 AnalyzerAlere Technologies AS
K142789A1c IGear SystemSakae Corporation

Global Unique Device Identification Database

00381933070019ASSAY, GLYCOSYLATED HEMOGLOBIN
00381933030013ASSAY, GLYCOSYLATED HEMOGLOBIN
00381933024012ASSAY, GLYCOSYLATED HEMOGLOBIN
00381933021011ASSAY, GLYCOSYLATED HEMOGLOBIN
00380740007836ASSAY, GLYCOSYLATED HEMOGLOBIN
00380740007812ASSAY, GLYCOSYLATED HEMOGLOBIN
00380740003616ASSAY, GLYCOSYLATED HEMOGLOBIN
00311917169835Assay, Glycosylated Hemoglobin
00630414596129ASSAY, GLYCOSYLATED HEMOGLOBIN
00630414595580ASSAY, GLYCOSYLATED HEMOGLOBIN
00630414571270ASSAY, GLYCOSYLATED HEMOGLOBIN
00630414569512ASSAY, GLYCOSYLATED HEMOGLOBIN
00630414558080ASSAY, GLYCOSYLATED HEMOGLOBIN
00630414558073ASSAY, GLYCOSYLATED HEMOGLOBIN
00630414555140ASSAY, GLYCOSYLATED HEMOGLOBIN

Maude Adverse Events

HBA1C III TINA-QUANT HEMOGLOBIN A1C IIIROCHE DIAGNOSTICS2020-02-24
G8G8TOSOH CORPORATION2020-02-18
G8G8TOSOH CORPORATION2020-02-13
HBA1C III TINA-QUANT HEMOGLOBIN A1C IIIROCHE DIAGNOSTICS2020-02-13
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2020-02-05
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2020-02-05
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2020-01-30
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2020-01-08
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-11-21
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-10-04
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-10-03
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-09-26
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-09-17
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-08-02
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-07-25
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-07-17
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-06-28
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-06-28
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-06-07
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-05-20
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-05-15
TOSOH HLC-723G8 ANALYZER G8TOSOH BIOSCIENCE, INC.2019-05-02
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-29
DIMENSION?SIEMENS HEALTHCARE DIAGNOSTICS INC.2019-04-29
G8G8TOSOH CORPORATION2019-04-25
G8G8TOSOH CORPORATION2019-04-25
G8G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-04-25
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-04-25
COBAS B 101 HBA1C TESTROCHE DIAGNOSTICS2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-25
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-24
TOSOH HLC-723G8 ANALYZER G8TOSOH BIOSCIENCE, INC.2019-04-24
TOSOH AUTOMATED GLYCOHEMOGLOBIN ANALYZER HLC-723 GXTOSOH CORPORATION2019-04-24
TOSOH HLC-723G8 ANALYZER G8TOSOH CORPORATION2019-04-24
TOSOH HLC-723G8 ANALYZER G8TOSOH BIOSCIENCE, INC.2019-04-24
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