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FDA 510(k)

CI-TROL COAGULATION CONTROLS II & III

K-Number: K771346 · 1977-08-22

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-08-22
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CI-TROL COAGULATION CONTROLS II & III is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-08-22 under 510(k) number K771346. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CI-TROL COAGULATION CONTROLS II & III?

CI-TROL COAGULATION CONTROLS II & III is a medical device that received FDA 510(k) clearance on 1977-08-22. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K771346.

When did CI-TROL COAGULATION CONTROLS II & III receive FDA 510(k) clearance?

CI-TROL COAGULATION CONTROLS II & III received FDA 510(k) clearance on 1977-08-22, under 510(k) number K771346.

Who is the listed applicant for CI-TROL COAGULATION CONTROLS II & III?

The FDA 510(k) record lists Dade, Baxter Travenol Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CI-TROL COAGULATION CONTROLS II & III?

The FDA product code for CI-TROL COAGULATION CONTROLS II & III is GGN.

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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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