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FDA 510(k)

CARESIDE GLUCOSE

K-Number: K981183 · 1998-05-07

ApplicantExigent Diagnostics, Inc.
Decision Date1998-05-07
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Exigent Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-05-07 under 510(k) number K981183. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE GLUCOSE?

CARESIDE GLUCOSE is a medical device that received FDA 510(k) clearance on 1998-05-07. The listed applicant is Exigent Diagnostics, Inc.. The 510(k) number is K981183.

When did CARESIDE GLUCOSE receive FDA 510(k) clearance?

CARESIDE GLUCOSE received FDA 510(k) clearance on 1998-05-07, under 510(k) number K981183.

Who is the listed applicant for CARESIDE GLUCOSE?

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

What is the FDA product code for CARESIDE GLUCOSE?

The FDA product code for CARESIDE GLUCOSE is CGA.

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Other records listing Exigent Diagnostics, 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.

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Related Devices (Code: CGA)

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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