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FDA 510(k)

MAGNESIUM REAGENT

K-Number: K800327 · 1980-03-25

ApplicantAlta Diagnostics, Inc.
Decision Date1980-03-25
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGNESIUM REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alta Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800327. 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 MAGNESIUM REAGENT?

MAGNESIUM REAGENT is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Alta Diagnostics, Inc.. The 510(k) number is K800327.

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

MAGNESIUM REAGENT received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800327.

Who is the listed applicant for MAGNESIUM REAGENT?

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

What is the FDA product code for MAGNESIUM REAGENT?

The FDA product code for MAGNESIUM REAGENT is JGJ.

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 Alta Diagnostics, 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.

K792545URIC ACID KITK792546FETAL CHECKK790797AMYLASE REAGENT SETK790796LIPASE REAGENT SET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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