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FDA 510(k)

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

K-Number: K080618 · 2008-05-23

ApplicantJas Diagnostics, Inc.
Decision Date2008-05-23
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-05-23 under 510(k) number K080618. 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 DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID?

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID is a medical device that received FDA 510(k) clearance on 2008-05-23. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K080618.

When did DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID receive FDA 510(k) clearance?

DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID received FDA 510(k) clearance on 2008-05-23, under 510(k) number K080618.

Who is the listed applicant for DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID?

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

What is the FDA product code for DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID?

The FDA product code for DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID is LCP.

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Other records listing Jas Diagnostics, Inc. as applicant

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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.

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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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