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FDA 510(k)

MAGNESIUM TEST ITEM NUMBER: SR1019

K-Number: K885022 · 1989-01-17

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-01-17
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGNESIUM TEST ITEM NUMBER: SR1019 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 1989-01-17 under 510(k) number K885022. 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 TEST ITEM NUMBER: SR1019?

MAGNESIUM TEST ITEM NUMBER: SR1019 is a medical device that received FDA 510(k) clearance on 1989-01-17. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K885022.

When did MAGNESIUM TEST ITEM NUMBER: SR1019 receive FDA 510(k) clearance?

MAGNESIUM TEST ITEM NUMBER: SR1019 received FDA 510(k) clearance on 1989-01-17, under 510(k) number K885022.

Who is the listed applicant for MAGNESIUM TEST ITEM NUMBER: SR1019?

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 MAGNESIUM TEST ITEM NUMBER: SR1019?

The FDA product code for MAGNESIUM TEST ITEM NUMBER: SR1019 is JGJ.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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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