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FDA 510(k)

CARESIDE ANALYZER

K-Number: K993634 · 1999-12-02

ApplicantCareside, Inc.
Decision Date1999-12-02
Product CodeJJF
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 1999-12-02 under 510(k) number K993634. The device is classified under product code JJF. 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 1999-12-02. The listed applicant is Careside, Inc.. The 510(k) number is K993634.

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

CARESIDE ANALYZER received FDA 510(k) clearance on 1999-12-02, under 510(k) number K993634.

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 JJF.

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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: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVAVital Scientific N.V.

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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