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FDA 510(k)

EZCHEK/HBA BLOOD COLLECTION KIT

K-Number: K971919 · 1997-09-05

ApplicantFlexsite Diagnostics, Inc.
Decision Date1997-09-05
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EZCHEK/HBA BLOOD COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Flexsite Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K971919. 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 EZCHEK/HBA BLOOD COLLECTION KIT?

EZCHEK/HBA BLOOD COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Flexsite Diagnostics, Inc.. The 510(k) number is K971919.

When did EZCHEK/HBA BLOOD COLLECTION KIT receive FDA 510(k) clearance?

EZCHEK/HBA BLOOD COLLECTION KIT received FDA 510(k) clearance on 1997-09-05, under 510(k) number K971919.

Who is the listed applicant for EZCHEK/HBA BLOOD COLLECTION KIT?

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

What is the FDA product code for EZCHEK/HBA BLOOD COLLECTION KIT?

The FDA product code for EZCHEK/HBA BLOOD COLLECTION KIT is LCP.

Related Clinical Trials

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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Other records listing Flexsite Diagnostics, 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.

K001810URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING

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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