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FDA 510(k)

TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC

K-Number: K853853 · 1985-10-03

ApplicantTechnicon Instruments Corp.
Decision Date1985-10-03
Product CodeJGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1985-10-03 under 510(k) number K853853. 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 TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC?

TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC is a medical device that received FDA 510(k) clearance on 1985-10-03. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K853853.

When did TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC receive FDA 510(k) clearance?

TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC received FDA 510(k) clearance on 1985-10-03, under 510(k) number K853853.

Who is the listed applicant for TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC?

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

What is the FDA product code for TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC?

The FDA product code for TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC is JGJ.

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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.

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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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