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FDA 510(k)

GLYCO-GEL TEST KIT

K-Number: K820279 · 1982-04-08

ApplicantPierce Chemical Co.
Decision Date1982-04-08
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCO-GEL TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pierce Chemical Co.. It received FDA 510(k) clearance on 1982-04-08 under 510(k) number K820279. 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-GEL TEST KIT?

GLYCO-GEL TEST KIT is a medical device that received FDA 510(k) clearance on 1982-04-08. The listed applicant is Pierce Chemical Co.. The 510(k) number is K820279.

When did GLYCO-GEL TEST KIT receive FDA 510(k) clearance?

GLYCO-GEL TEST KIT received FDA 510(k) clearance on 1982-04-08, under 510(k) number K820279.

Who is the listed applicant for GLYCO-GEL TEST KIT?

The FDA 510(k) record lists Pierce Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCO-GEL TEST KIT?

The FDA product code for GLYCO-GEL TEST KIT is LCP.

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Other records listing Pierce Chemical Co. 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.

K895661GLYCOTEST II GLYHB ASSAY KITK831837CLINOVATIVE II DIAGNOSTIC KITK821360GLYCO-GEL TEST KITK781897STAT KIT, MICROPROTEINK780827URIC ACID RAPID STAT KITK780826BILIRUBIN RAPID STAT KIT

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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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