Glyco-Sep Reagent Test Set

Q: What is the product code of K820076?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.

FDA 510(k) K820076 · Clin Tech Diagnostics Corp.

Substantially Equivalent

510(k) numberK820076

Submission

Device name: Glyco-Sep Reagent Test Set
Applicant: Clin Tech Diagnostics Corp.
Mchenry, IL, US
Received: January 12, 1982
Decision date: February 12, 1982
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: LCP – Assay, Glycosylated Hemoglobin
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7470
Specialty: Hematology

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K180509	Quo-Test A1c SystemLCP · Dual Track	Ekf-Diagnostic GmbH	02/16/2019SE
K173127	skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional	Skyla Corporation H.S.P.B	09/25/2018SE
K170623	ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional	Alfa Wassermann Diagnostic Technologies, LLC	02/27/2018SE

More from Alfa Wassermann Diagnostic Technologies, LLC

510(k)	Device	Decision
K821969	Acetaminophen Stat-Pak Reagent SetLDP · Traditional	07/16/1982SE
K813185	Salicylate Stat-PakDKJ · Traditional	11/24/1981SE
K810235	Acetaminophen/Salicylate ControlDIF · Traditional	02/10/1981SE
K802432	Glyco-Trol Human Glycosylated Hom. Cont.LCP · Traditional	12/01/1980SE

Questions and answers

When was Glyco-Sep Reagent Test Set cleared by the FDA?

Glyco-Sep Reagent Test Set (K820076) received a 510(k) decision of Substantially Equivalent on February 12, 1982, 31 days after the submission was received.

What is the product code of K820076?

The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.