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FDA 510(k)

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III

K-Number: K911178 · 1991-05-01

ApplicantAnalytical Control Systems, Inc.
Decision Date1991-05-01
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL 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 1991-05-01 under 510(k) number K911178. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III?

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III 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 K911178.

When did ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III receive FDA 510(k) clearance?

ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III received FDA 510(k) clearance on 1991-05-01, under 510(k) number K911178.

Who is the listed applicant for ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL 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 MONITORING CONTROL, LEVEL III?

The FDA product code for ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III is JJX.

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Other records listing Analytical Control Systems, Inc. as applicant

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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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