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FDA 510(k)

ATAC PAK MAGNESIUM REAGENT

K-Number: K030010 · 2003-03-10

ApplicantElan Diagnostics
Decision Date2003-03-10
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ATAC PAK MAGNESIUM REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Diagnostics. It received FDA 510(k) clearance on 2003-03-10 under 510(k) number K030010. The device is classified under product code JGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATAC PAK MAGNESIUM REAGENT?

ATAC PAK MAGNESIUM REAGENT is a medical device that received FDA 510(k) clearance on 2003-03-10. The listed applicant is Elan Diagnostics. The 510(k) number is K030010.

When did ATAC PAK MAGNESIUM REAGENT receive FDA 510(k) clearance?

ATAC PAK MAGNESIUM REAGENT received FDA 510(k) clearance on 2003-03-10, under 510(k) number K030010.

Who is the listed applicant for ATAC PAK MAGNESIUM REAGENT?

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

What is the FDA product code for ATAC PAK MAGNESIUM REAGENT?

The FDA product code for ATAC PAK MAGNESIUM REAGENT is JGJ.

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Other records listing Elan Diagnostics 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.

K030003ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATORK030014ATAC TOTAL BILIRUBIN REAGENTK030621ATAC CALIBRATORK023105ATAC CALCIUM REAGENT AND ATAC CALIBRATORK030015ATAC PAK PHOSPHORUS REAGENTK030006ATAC PAK ALBUMIN REAGENT

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Related Devices (Code: JGJ)

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.

K181748MagnesiumAbbott LaboratoriesK173294MagnesiumAbbott LaboratoriesK162200Randox RX Daytona Plus Magnesium (MG)Randox Laboratories, Ltd.K162399Atellica CH Magnesium (Mg)Siemens Healthcare Diagnostics, Inc.K122302ACE MAGNESIUM REGENTAlfa Wassermann Diagnostics Technologies, LLCK111915MAGNESIUM ASSAYSekisui Diagnostics P.E.I., Inc.

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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