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FDA 510(k)

CARESIDE PT

K-Number: K991065 · 1999-07-26

ApplicantCareside, Inc.
Decision Date1999-07-26
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CARESIDE PT is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 1999-07-26 under 510(k) number K991065. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE PT?

CARESIDE PT is a medical device that received FDA 510(k) clearance on 1999-07-26. The listed applicant is Careside, Inc.. The 510(k) number is K991065.

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

CARESIDE PT received FDA 510(k) clearance on 1999-07-26, under 510(k) number K991065.

Who is the listed applicant for CARESIDE PT?

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 PT?

The FDA product code for CARESIDE PT is GJS.

Related Clinical Trials

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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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

View all 22 devices →

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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