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FDA 510(k)

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC

K-Number: K991850 · 1999-11-26

ApplicantBiosafe Laboratories, Inc.
Decision Date1999-11-26
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC is the device name listed in this FDA 510(k) record. The listed applicant is Biosafe Laboratories, Inc.. It received FDA 510(k) clearance on 1999-11-26 under 510(k) number K991850. 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 SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC?

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC is a medical device that received FDA 510(k) clearance on 1999-11-26. The listed applicant is Biosafe Laboratories, Inc.. The 510(k) number is K991850.

When did SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC receive FDA 510(k) clearance?

SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC received FDA 510(k) clearance on 1999-11-26, under 510(k) number K991850.

Who is the listed applicant for SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC?

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

What is the FDA product code for SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC?

The FDA product code for SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC is LCP.

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Other records listing Biosafe Laboratories, 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.

K042379ANEMIAPRO SELF-SCREENERK012221SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEMK011970BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEMK011525SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)K003752BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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