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FDA 510(k)

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III

K-Number: K913677 · 1991-09-25

ApplicantAnalytical Control Systems, Inc.
Decision Date1991-09-25
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III 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 1991-09-25 under 510(k) number K913677. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III?

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K913677.

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

ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913677.

Who is the listed applicant for ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III?

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 CONTOLS, LEVEL I,II,III?

The FDA product code for ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III is LAS.

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Other records listing Analytical Control Systems, Inc. as applicant

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Related Devices (Code: LAS)

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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