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FDA 510(k)

JAS MAGNESIUM REAGENT

K-Number: K003835 · 2001-03-23

ApplicantJas Diagnostics, Inc.
Decision Date2001-03-23
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

JAS MAGNESIUM REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Jas Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-03-23 under 510(k) number K003835. 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 JAS MAGNESIUM REAGENT?

JAS MAGNESIUM REAGENT is a medical device that received FDA 510(k) clearance on 2001-03-23. The listed applicant is Jas Diagnostics, Inc.. The 510(k) number is K003835.

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

JAS MAGNESIUM REAGENT received FDA 510(k) clearance on 2001-03-23, under 510(k) number K003835.

Who is the listed applicant for JAS MAGNESIUM REAGENT?

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

What is the FDA product code for JAS MAGNESIUM REAGENT?

The FDA product code for JAS MAGNESIUM REAGENT is JGJ.

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Other records listing Jas 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.

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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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