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FDA 510(k)

MAGNESIUM REAGENT - CALMAGITE METHOD

K-Number: K870370 · 1987-08-19

ApplicantTrace Scientific , Ltd.
Decision Date1987-08-19
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGNESIUM REAGENT - CALMAGITE METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-08-19 under 510(k) number K870370. 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 - CALMAGITE METHOD?

MAGNESIUM REAGENT - CALMAGITE METHOD is a medical device that received FDA 510(k) clearance on 1987-08-19. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K870370.

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

MAGNESIUM REAGENT - CALMAGITE METHOD received FDA 510(k) clearance on 1987-08-19, under 510(k) number K870370.

Who is the listed applicant for MAGNESIUM REAGENT - CALMAGITE METHOD?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGNESIUM REAGENT - CALMAGITE METHOD?

The FDA product code for MAGNESIUM REAGENT - CALMAGITE METHOD is JGJ.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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