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FDA 510(k)

GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.

K-Number: K802432 · 1980-12-01

ApplicantClin Tech Diagnostics Corp.
Decision Date1980-12-01
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. 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 1980-12-01 under 510(k) number K802432. 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-TROL HUMAN GLYCOSYLATED HOM. CONT.?

GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. is a medical device that received FDA 510(k) clearance on 1980-12-01. The listed applicant is Clin Tech Diagnostics Corp.. The 510(k) number is K802432.

When did GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. receive FDA 510(k) clearance?

GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. received FDA 510(k) clearance on 1980-12-01, under 510(k) number K802432.

Who is the listed applicant for GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT.?

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-TROL HUMAN GLYCOSYLATED HOM. CONT.?

The FDA product code for GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. 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.

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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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