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FDA 510(k)

ACS LIQUID THROMBOPLASTIN

K-Number: K912102 · 1991-08-09

ApplicantAnalytical Control Systems, Inc.
Decision Date1991-08-09
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS LIQUID THROMBOPLASTIN 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 1991-08-09 under 510(k) number K912102. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS LIQUID THROMBOPLASTIN?

ACS LIQUID THROMBOPLASTIN is a medical device that received FDA 510(k) clearance on 1991-08-09. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K912102.

When did ACS LIQUID THROMBOPLASTIN receive FDA 510(k) clearance?

ACS LIQUID THROMBOPLASTIN received FDA 510(k) clearance on 1991-08-09, under 510(k) number K912102.

Who is the listed applicant for ACS LIQUID THROMBOPLASTIN?

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 LIQUID THROMBOPLASTIN?

The FDA product code for ACS LIQUID THROMBOPLASTIN is GJS.

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Other records listing Analytical Control Systems, Inc. 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.

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Related Devices (Code: GJS)

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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