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FDA 510(k)

MG REAGENT

K-Number: K852005 · 1985-06-25

ApplicantAlpkem Corp.
Decision Date1985-06-25
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MG REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Alpkem Corp.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K852005. 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 MG REAGENT?

MG REAGENT is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Alpkem Corp.. The 510(k) number is K852005.

When did MG REAGENT receive FDA 510(k) clearance?

MG REAGENT received FDA 510(k) clearance on 1985-06-25, under 510(k) number K852005.

Who is the listed applicant for MG REAGENT?

The FDA 510(k) record lists Alpkem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MG REAGENT?

The FDA product code for MG REAGENT is JGJ.

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Other records listing Alpkem Corp. 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.

K894011TOTAL GALACTOSEK891070PHENYLALANINE (NINHYDRIN REACTION)K890334TOTAL CHOLESTEROL REAGENTK890337TRIGLYCERIDES - GPO REAGENTK890336GLUCOSE (GOD) REAGENTK890332RFA/2 RAPID FLOW ANALYZER W/COMPUTER

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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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