Q-Pak Chemistry Radioreceptor Control C

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K770012 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Low Ionic Strength Solution (Liss)

  Class II

  FDA 510(k) K791113 Active Cleared 28 Jun 1979

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  Class I

  FDA 510(k) K772085 Active Cleared 24 Jan 1978

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  Not classified

  FDA 510(k) K771700 Active Cleared 11 Nov 1977

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  FDA 510(k) K771226 Active Cleared 21 Jul 1977

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  FDA 510(k) K771445 Active Cleared 14 Dec 1977

See all devices from Hyland Therapeutic Div., Travenol Laboratories →

• What is the Q-Pak Chemistry Radioreceptor Control C used for?

  The Q-Pak Chemistry Radioreceptor Control C is a calibrator and multi-analyte mixture specifically designed to serve as a control for radio receptor assays in clinical chemistry laboratory testing procedures.

• How is the Q-Pak Chemistry Radioreceptor Control C supplied?

  The device is supplied by Hyland Therapeutic Division, Travenol Laboratories. It is manufactured in McHenry, IL, US, and is authorized under FDA 510(k) clearance K770012.

• What is the regulatory classification of the Q-Pak Chemistry Radioreceptor Control C?

  The Q-Pak Chemistry Radioreceptor Control C is a Class II medical device regulated under product code JIX and regulation number 862.1150. It received FDA 510(k) clearance in 1977 with decision code SESE, indicating it is substantially equivalent to other devices on the market.

• What advisory committee reviewed the Q-Pak Chemistry Radioreceptor Control C?

  The device was reviewed by the Clinical Chemistry advisory committee (CH) under the review advisory committee IM. This indicates it was evaluated for its use in clinical chemistry laboratory settings.