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FDA 510(k)

THERAPEUTIC DRUG MONITORING CONTROL SET

K-Number: K862963 · 1986-09-15

ApplicantAmerican Monitor Corp.
Decision Date1986-09-15
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THERAPEUTIC DRUG MONITORING CONTROL SET 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 1986-09-15 under 510(k) number K862963. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAPEUTIC DRUG MONITORING CONTROL SET?

THERAPEUTIC DRUG MONITORING CONTROL SET is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is American Monitor Corp.. The 510(k) number is K862963.

When did THERAPEUTIC DRUG MONITORING CONTROL SET receive FDA 510(k) clearance?

THERAPEUTIC DRUG MONITORING CONTROL SET received FDA 510(k) clearance on 1986-09-15, under 510(k) number K862963.

Who is the listed applicant for THERAPEUTIC DRUG MONITORING CONTROL SET?

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 THERAPEUTIC DRUG MONITORING CONTROL SET?

The FDA product code for THERAPEUTIC DRUG MONITORING CONTROL SET is JJY.

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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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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Related Devices (Code: JJY)

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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