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FDA 510(k)

CARESIDE GLOBULIN

K-Number: K980055 · 1998-01-28

ApplicantExigent Diagnostics, Inc.
Decision Date1998-01-28
Product CodeJGE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE GLOBULIN 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 1998-01-28 under 510(k) number K980055. The device is classified under product code JGE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE GLOBULIN?

CARESIDE GLOBULIN is a medical device that received FDA 510(k) clearance on 1998-01-28. The listed applicant is Exigent Diagnostics, Inc.. The 510(k) number is K980055.

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

CARESIDE GLOBULIN received FDA 510(k) clearance on 1998-01-28, under 510(k) number K980055.

Who is the listed applicant for CARESIDE GLOBULIN?

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 GLOBULIN?

The FDA product code for CARESIDE GLOBULIN is JGE.

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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.

K982118CARESIDE ANALYZERK981899CARESIDE HDL-CHOLESTEROLK981183CARESIDE GLUCOSEK980043CARESIDE CREATININEK980056CARESIDE ANALYZERK980057CARESIDE BUN

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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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