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FDA 510(k)

VARIANT(TM) II TURBO HBA1C KIT - 2.0

K-Number: K130990 · 2013-05-09

ApplicantBio-Rad Laboratories, Inc., Clinical Systems Divis
Decision Date2013-05-09
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT(TM) II TURBO HBA1C KIT - 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc., Clinical Systems Divis. It received FDA 510(k) clearance on 2013-05-09 under 510(k) number K130990. 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 VARIANT(TM) II TURBO HBA1C KIT - 2.0?

VARIANT(TM) II TURBO HBA1C KIT - 2.0 is a medical device that received FDA 510(k) clearance on 2013-05-09. The listed applicant is Bio-Rad Laboratories, Inc., Clinical Systems Divis. The 510(k) number is K130990.

When did VARIANT(TM) II TURBO HBA1C KIT - 2.0 receive FDA 510(k) clearance?

VARIANT(TM) II TURBO HBA1C KIT - 2.0 received FDA 510(k) clearance on 2013-05-09, under 510(k) number K130990.

Who is the listed applicant for VARIANT(TM) II TURBO HBA1C KIT - 2.0?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc., Clinical Systems Divis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VARIANT(TM) II TURBO HBA1C KIT - 2.0?

The FDA product code for VARIANT(TM) II TURBO HBA1C KIT - 2.0 is LCP.

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Other records listing Bio-Rad Laboratories, Inc., Clinical Systems Divis 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.

K130860VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWAREK122472VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM

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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