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FDA 510(k)

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7

K-Number: K063208 · 2007-01-19

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2007-01-19
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2007-01-19 under 510(k) number K063208. 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 ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7?

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 is a medical device that received FDA 510(k) clearance on 2007-01-19. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K063208.

When did MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 receive FDA 510(k) clearance?

MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 received FDA 510(k) clearance on 2007-01-19, under 510(k) number K063208.

Who is the listed applicant for MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7?

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

What is the FDA product code for MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7?

The FDA product code for MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7 is JGJ.

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Other records listing Diagnostic Chemicals , 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.

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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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