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FDA 510(k)

ACTIVATED URIC ACID

K-Number: K830616 · 1983-04-05

ApplicantAmerican Monitor Corp.
Decision Date1983-04-05
Product CodeCHD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACTIVATED URIC ACID is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830616. The device is classified under product code CHD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIVATED URIC ACID?

ACTIVATED URIC ACID is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is American Monitor Corp.. The 510(k) number is K830616.

When did ACTIVATED URIC ACID receive FDA 510(k) clearance?

ACTIVATED URIC ACID received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830616.

Who is the listed applicant for ACTIVATED URIC ACID?

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

What is the FDA product code for ACTIVATED URIC ACID?

The FDA product code for ACTIVATED URIC ACID is CHD.

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Other records listing American Monitor 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: CHD)

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.

K841052CHOLESTEROL REAGENT SETMedical Specialties, Inc.K821195CHOLESTEROL REAGENT SETOmega Medical Electronics

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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