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FDA 510(k)

ACS FREEZE-DRIED APTT REAGENT

K-Number: K921223 · 1992-08-18

ApplicantAnalytical Control Systems, Inc.
Decision Date1992-08-18
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS FREEZE-DRIED APTT 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 1992-08-18 under 510(k) number K921223. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS FREEZE-DRIED APTT REAGENT?

ACS FREEZE-DRIED APTT REAGENT is a medical device that received FDA 510(k) clearance on 1992-08-18. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K921223.

When did ACS FREEZE-DRIED APTT REAGENT receive FDA 510(k) clearance?

ACS FREEZE-DRIED APTT REAGENT received FDA 510(k) clearance on 1992-08-18, under 510(k) number K921223.

Who is the listed applicant for ACS FREEZE-DRIED APTT 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 FREEZE-DRIED APTT REAGENT?

The FDA product code for ACS FREEZE-DRIED APTT REAGENT is GFO.

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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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