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FDA 510(k)

ACS ULTRA-1 THROMBOPLASTIN

K-Number: K913249 · 1991-12-04

ApplicantAnalytical Control Systems, Inc.
Decision Date1991-12-04
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS ULTRA-1 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 1991-12-04 under 510(k) number K913249. 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 ULTRA-1 THROMBOPLASTIN?

ACS ULTRA-1 THROMBOPLASTIN is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K913249.

When did ACS ULTRA-1 THROMBOPLASTIN receive FDA 510(k) clearance?

ACS ULTRA-1 THROMBOPLASTIN received FDA 510(k) clearance on 1991-12-04, under 510(k) number K913249.

Who is the listed applicant for ACS ULTRA-1 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 ULTRA-1 THROMBOPLASTIN?

The FDA product code for ACS ULTRA-1 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)

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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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