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FDA 510(k)

MAGNESIUM REAGENT FOR DEMAND ANALYZER

K-Number: K850381 · 1985-03-01

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1985-03-01
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAGNESIUM REAGENT FOR DEMAND ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850381. 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 REAGENT FOR DEMAND ANALYZER?

MAGNESIUM REAGENT FOR DEMAND ANALYZER is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K850381.

When did MAGNESIUM REAGENT FOR DEMAND ANALYZER receive FDA 510(k) clearance?

MAGNESIUM REAGENT FOR DEMAND ANALYZER received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850381.

Who is the listed applicant for MAGNESIUM REAGENT FOR DEMAND ANALYZER?

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

What is the FDA product code for MAGNESIUM REAGENT FOR DEMAND ANALYZER?

The FDA product code for MAGNESIUM REAGENT FOR DEMAND ANALYZER is JGJ.

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Other records listing Advanced Biomedical Methods, 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.

K945353CLARIT(TM)K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERK864866RESUBMISSION OF THE KLEERZIT REAGENTK852784ALKALINE PHOSPHATASEK852783SGOT/ALT REAGENTK852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZER

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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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