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FDA 510(k)

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183

K-Number: K905673 · 1991-02-11

ApplicantHelena Laboratories
Decision Date1991-02-11
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905673. 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 AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183?

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Helena Laboratories. The 510(k) number is K905673.

When did AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 receive FDA 510(k) clearance?

AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905673.

Who is the listed applicant for AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183?

The FDA product code for AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 is GGN.

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Other records listing Helena Laboratories 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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