FDA 510(k)

ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II

K-Number: K911167 · 1991-05-01

ApplicantAnalytical Control Systems, Inc.

Decision Date1991-05-01

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Control Systems, Inc.. It received FDA 510(k) clearance on 1991-05-01 under 510(k) number K911167. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II?

ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II is a medical device that received FDA 510(k) clearance on 1991-05-01. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K911167.

When did ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II receive FDA 510(k) clearance?

ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II received FDA 510(k) clearance on 1991-05-01, under 510(k) number K911167.

Who is the listed applicant for ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II?

The FDA 510(k) record lists Analytical Control Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II?

The FDA product code for ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II is DIF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.