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FDA 510(k)

GLYCOHEMOGLOBIN-SKREEN TEST KIT

K-Number: K780819 · 1978-11-07

ApplicantEppendorf-Brinkmann, Inc.
Decision Date1978-11-07
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GLYCOHEMOGLOBIN-SKREEN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Eppendorf-Brinkmann, Inc.. It received FDA 510(k) clearance on 1978-11-07 under 510(k) number K780819. 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 GLYCOHEMOGLOBIN-SKREEN TEST KIT?

GLYCOHEMOGLOBIN-SKREEN TEST KIT is a medical device that received FDA 510(k) clearance on 1978-11-07. The listed applicant is Eppendorf-Brinkmann, Inc.. The 510(k) number is K780819.

When did GLYCOHEMOGLOBIN-SKREEN TEST KIT receive FDA 510(k) clearance?

GLYCOHEMOGLOBIN-SKREEN TEST KIT received FDA 510(k) clearance on 1978-11-07, under 510(k) number K780819.

Who is the listed applicant for GLYCOHEMOGLOBIN-SKREEN TEST KIT?

The FDA 510(k) record lists Eppendorf-Brinkmann, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCOHEMOGLOBIN-SKREEN TEST KIT?

The FDA product code for GLYCOHEMOGLOBIN-SKREEN TEST KIT is LCP.

Related Clinical Trials

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Other records listing Eppendorf-Brinkmann, Inc. 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.

K772337URINARY 17-KETOSTERIOD/17K772151URINARY VMA - SCREEN TEST KITK761271URIN. L7-OH CORTICOSTEROID T(NON HYDRO)

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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