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FDA 510(k)

CARESIDE ANALYZER

K-Number: K981610 · 1998-06-25

ApplicantCareside, Inc.
Decision Date1998-06-25
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 1998-06-25 under 510(k) number K981610. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE ANALYZER?

CARESIDE ANALYZER is a medical device that received FDA 510(k) clearance on 1998-06-25. The listed applicant is Careside, Inc.. The 510(k) number is K981610.

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

CARESIDE ANALYZER received FDA 510(k) clearance on 1998-06-25, under 510(k) number K981610.

Who is the listed applicant for CARESIDE ANALYZER?

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

What is the FDA product code for CARESIDE ANALYZER?

The FDA product code for CARESIDE ANALYZER is CEO.

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Other records listing Careside, 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.

K020484CARESIDE LDHK020486CARESIDE GGTK020487CARESIDE ALTK020488CARESIDE TRGLYCERIDEK002792CARESIDE CHOLINESTERASEK001462CARESIDE HEMOGLOBIN

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Related Devices (Code: CEO)

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.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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