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FDA 510(k)

EMDS MAGNESIUM (MG) TEST

K-Number: K935183 · 1993-12-09

ApplicantEm Diagnostic Systems, Inc.
Decision Date1993-12-09
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS MAGNESIUM (MG) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1993-12-09 under 510(k) number K935183. 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 EMDS MAGNESIUM (MG) TEST?

EMDS MAGNESIUM (MG) TEST is a medical device that received FDA 510(k) clearance on 1993-12-09. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K935183.

When did EMDS MAGNESIUM (MG) TEST receive FDA 510(k) clearance?

EMDS MAGNESIUM (MG) TEST received FDA 510(k) clearance on 1993-12-09, under 510(k) number K935183.

Who is the listed applicant for EMDS MAGNESIUM (MG) TEST?

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

What is the FDA product code for EMDS MAGNESIUM (MG) TEST?

The FDA product code for EMDS MAGNESIUM (MG) TEST is JGJ.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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