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FDA 510(k)

BIOTROL MAGNESIUM (MAGON)

K-Number: K921677 · 1992-05-26

ApplicantBiotrol, USA, Inc.
Decision Date1992-05-26
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOTROL MAGNESIUM (MAGON) is the device name listed in this FDA 510(k) record. The listed applicant is Biotrol, USA, Inc.. It received FDA 510(k) clearance on 1992-05-26 under 510(k) number K921677. 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 BIOTROL MAGNESIUM (MAGON)?

BIOTROL MAGNESIUM (MAGON) is a medical device that received FDA 510(k) clearance on 1992-05-26. The listed applicant is Biotrol, USA, Inc.. The 510(k) number is K921677.

When did BIOTROL MAGNESIUM (MAGON) receive FDA 510(k) clearance?

BIOTROL MAGNESIUM (MAGON) received FDA 510(k) clearance on 1992-05-26, under 510(k) number K921677.

Who is the listed applicant for BIOTROL MAGNESIUM (MAGON)?

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

What is the FDA product code for BIOTROL MAGNESIUM (MAGON)?

The FDA product code for BIOTROL MAGNESIUM (MAGON) is JGJ.

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Other records listing Biotrol, USA, Inc. as applicant

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K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTK931141BIOTROL AMYLASE CNPG3K921855BIOTROL BICARBONATE STANDARDSK912795BIOTROL UIBC REAGENTK910721BIOTROL PROTEIN MULTILEVEL STANDARDSK905683BIOTROL LACTATE DEHYDROGENASE (L-P)

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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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