Lucica Glycated Albumin-L
K-Number: K170147 · 2017-10-12
ApplicantAsahi Kasei Pharma Corporation
Decision Date2017-10-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Lucica Glycated Albumin-L is a medical device manufactured by Asahi Kasei Pharma Corporation. It received FDA 510(k) clearance on 2017-10-12 under approval number K170147. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Lucica Glycated Albumin-L?
Lucica Glycated Albumin-L is a medical device that received FDA 510(k) clearance on 2017-10-12. It is manufactured by Asahi Kasei Pharma Corporation. The 510(k) number is K170147.
When was Lucica Glycated Albumin-L approved by the FDA?
Lucica Glycated Albumin-L received FDA 510(k) clearance on 2017-10-12, under approval number K170147.
What company makes Lucica Glycated Albumin-L?
Lucica Glycated Albumin-L is manufactured by Asahi Kasei Pharma Corporation.
What is the FDA product code for Lucica Glycated Albumin-L?
The FDA product code for Lucica Glycated Albumin-L is LCP.
Related Devices (Code: LCP)
K160762Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control SetDiazyme Laboratories
K142664URight Hemoglobin A1c system, FORA A1c SystemTaidoc Technology Corporation
K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics
K163633cobas HbA1c Test, cobas b 101 systemRoche Diagnostics Operations
K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd.
K162281CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)Sebia
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.