FDA 510(k)

Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S

K-Number: K810078 · 1981-02-02

ApplicantHyland Therapeutic Div., Travenol Laboratories

Decision Date1981-02-02

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S is the device name listed in this FDA 510(k) record. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K810078. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S?

Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Hyland Therapeutic Div., Travenol Laboratories. The 510(k) number is K810078.

When did Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S receive FDA 510(k) clearance?

Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S received FDA 510(k) clearance on 1981-02-02, under 510(k) number K810078.

Who is the listed applicant for Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S?

The FDA 510(k) record lists Hyland Therapeutic Div., Travenol Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S?

The FDA product code for Q-PAK THERAPEUTIC DRUG MONIT. CONTROL S is DIF.

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Other records listing Hyland Therapeutic Div., Travenol Laboratories as applicant

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Related Devices (Code: DIF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.