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FDA 510(k)

ACS ONE-STAGE PROTHROMBIN TIME REAGENT

K-Number: K902468 · 1990-08-10

ApplicantAnalytical Control Systems, Inc.
Decision Date1990-08-10
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS ONE-STAGE PROTHROMBIN TIME REAGENT 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 1990-08-10 under 510(k) number K902468. 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 ONE-STAGE PROTHROMBIN TIME REAGENT?

ACS ONE-STAGE PROTHROMBIN TIME REAGENT is a medical device that received FDA 510(k) clearance on 1990-08-10. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K902468.

When did ACS ONE-STAGE PROTHROMBIN TIME REAGENT receive FDA 510(k) clearance?

ACS ONE-STAGE PROTHROMBIN TIME REAGENT received FDA 510(k) clearance on 1990-08-10, under 510(k) number K902468.

Who is the listed applicant for ACS ONE-STAGE PROTHROMBIN TIME REAGENT?

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 ONE-STAGE PROTHROMBIN TIME REAGENT?

The FDA product code for ACS ONE-STAGE PROTHROMBIN TIME REAGENT 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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