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FDA 510(k)

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU

K-Number: K070452 · 2007-05-07

ApplicantBio-Rad Laboratories, Inc.
Decision Date2007-05-07
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2007-05-07 under 510(k) number K070452. 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 II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU?

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU is a medical device that received FDA 510(k) clearance on 2007-05-07. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K070452.

When did VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU receive FDA 510(k) clearance?

VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU received FDA 510(k) clearance on 2007-05-07, under 510(k) number K070452.

Who is the listed applicant for VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU?

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

What is the FDA product code for VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU?

The FDA product code for VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU is LCP.

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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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