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FDA 510(k)

ACS ULTRA-2 THROMBOPLASTIN

K-Number: K913250 · 1991-11-27

ApplicantAnalytical Control Systems, Inc.
Decision Date1991-11-27
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS ULTRA-2 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 1991-11-27 under 510(k) number K913250. 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-2 THROMBOPLASTIN?

ACS ULTRA-2 THROMBOPLASTIN is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K913250.

When did ACS ULTRA-2 THROMBOPLASTIN receive FDA 510(k) clearance?

ACS ULTRA-2 THROMBOPLASTIN received FDA 510(k) clearance on 1991-11-27, under 510(k) number K913250.

Who is the listed applicant for ACS ULTRA-2 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-2 THROMBOPLASTIN?

The FDA product code for ACS ULTRA-2 THROMBOPLASTIN is GJS.

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Other records listing Analytical Control Systems, Inc. as applicant

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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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