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FDA 510(k)

SERTROL PRODUCT # ACS ST 101

K-Number: K800559 · 1980-03-25

ApplicantAnalytical Control Systems, Inc.
Decision Date1980-03-25
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERTROL PRODUCT # ACS ST 101 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 1980-03-25 under 510(k) number K800559. 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 SERTROL PRODUCT # ACS ST 101?

SERTROL PRODUCT # ACS ST 101 is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K800559.

When did SERTROL PRODUCT # ACS ST 101 receive FDA 510(k) clearance?

SERTROL PRODUCT # ACS ST 101 received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800559.

Who is the listed applicant for SERTROL PRODUCT # ACS ST 101?

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 SERTROL PRODUCT # ACS ST 101?

The FDA product code for SERTROL PRODUCT # ACS ST 101 is JJY.

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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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