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FDA 510(k)

HEMOCHEK-A1C SAMPLE COLLECTION KIT

K-Number: K990899 · 1999-12-21

ApplicantOsborn Group, Inc.
Decision Date1999-12-21
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHEK-A1C SAMPLE COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Osborn Group, Inc.. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K990899. 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 HEMOCHEK-A1C SAMPLE COLLECTION KIT?

HEMOCHEK-A1C SAMPLE COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is Osborn Group, Inc.. The 510(k) number is K990899.

When did HEMOCHEK-A1C SAMPLE COLLECTION KIT receive FDA 510(k) clearance?

HEMOCHEK-A1C SAMPLE COLLECTION KIT received FDA 510(k) clearance on 1999-12-21, under 510(k) number K990899.

Who is the listed applicant for HEMOCHEK-A1C SAMPLE COLLECTION KIT?

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

What is the FDA product code for HEMOCHEK-A1C SAMPLE COLLECTION KIT?

The FDA product code for HEMOCHEK-A1C SAMPLE 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 Osborn Group, 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.

K002156APPRAISE URINE MICROALBUMIN COLLECTION KITK993787APPRAISE-CARDIO SAMPLE COLLECTION KITK991800HEMOCHEK URINE COLLECTION KIT

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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