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FDA 510(k)

CARESIDE ALT

K-Number: K020487 · 2002-06-04

ApplicantCareside, Inc.
Decision Date2002-06-04
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CARESIDE ALT is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 2002-06-04 under 510(k) number K020487. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESIDE ALT?

CARESIDE ALT is a medical device that received FDA 510(k) clearance on 2002-06-04. The listed applicant is Careside, Inc.. The 510(k) number is K020487.

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

CARESIDE ALT received FDA 510(k) clearance on 2002-06-04, under 510(k) number K020487.

Who is the listed applicant for CARESIDE ALT?

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 ALT?

The FDA product code for CARESIDE ALT is CKA.

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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 GGTK020488CARESIDE TRGLYCERIDEK002792CARESIDE CHOLINESTERASEK001462CARESIDE HEMOGLOBINK993771CARESIDE DIRECT BILIRUBIN

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.K974003ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30Diagnostic Chemicals , Ltd.

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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