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FDA 510(k)

GLYCO-SEP REAGENT TEST SET

K-Number: K820076 · 1982-02-12

ApplicantClin Tech Diagnostics Corp.
Decision Date1982-02-12
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCO-SEP REAGENT TEST SET is the device name listed in this FDA 510(k) record. The listed applicant is Clin Tech Diagnostics Corp.. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820076. 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 GLYCO-SEP REAGENT TEST SET?

GLYCO-SEP REAGENT TEST SET is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is Clin Tech Diagnostics Corp.. The 510(k) number is K820076.

When did GLYCO-SEP REAGENT TEST SET receive FDA 510(k) clearance?

GLYCO-SEP REAGENT TEST SET received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820076.

Who is the listed applicant for GLYCO-SEP REAGENT TEST SET?

The FDA 510(k) record lists Clin Tech Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCO-SEP REAGENT TEST SET?

The FDA product code for GLYCO-SEP REAGENT TEST SET is LCP.

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Other records listing Clin Tech Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K821969ACETAMINOPHEN STAT-PAK REAGENT SETK813185SALICYLATE STAT-PAKK810235ACETAMINOPHEN/SALICYLATE CONTROLK802432GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.

Related Devices (Code: LCP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina 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.

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.

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