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FDA 510(k)

Y-GLUTAMYLTRANSFERASE

K-Number: K813215 · 1981-12-08

ApplicantAmerican Monitor Corp.
Decision Date1981-12-08
Product Code
DecisionSubstantially Equivalent

Device Summary

Y-GLUTAMYLTRANSFERASE 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 1981-12-08 under 510(k) number K813215. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Y-GLUTAMYLTRANSFERASE?

Y-GLUTAMYLTRANSFERASE is a medical device that received FDA 510(k) clearance on 1981-12-08. The listed applicant is American Monitor Corp.. The 510(k) number is K813215.

When did Y-GLUTAMYLTRANSFERASE receive FDA 510(k) clearance?

Y-GLUTAMYLTRANSFERASE received FDA 510(k) clearance on 1981-12-08, under 510(k) number K813215.

Who is the listed applicant for Y-GLUTAMYLTRANSFERASE?

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

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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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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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