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FDA 510(k)

URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS

K-Number: K926144 · 1993-01-27

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-01-27
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1993-01-27 under 510(k) number K926144. 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 URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS?

URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K926144.

When did URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS receive FDA 510(k) clearance?

URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS received FDA 510(k) clearance on 1993-01-27, under 510(k) number K926144.

Who is the listed applicant for URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS?

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

What is the FDA product code for URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS?

The FDA product code for URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS is JGJ.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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