CA-1511, In Vitro Radioimmunoassay

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K841821 ↗

FDA Product Code

JHI

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Travenol Laboratories, S.A. →

• What is the CA-1511 In Vitro Radioimmunoassay used for?

  The CA-1511 is a diagnostic test system used for the quantitative measurement of human chorionic gonadotropin (hCG) in serum or plasma specimens. It is designed for laboratory use and is intended for prescription purposes.

• How is the CA-1511 Radioimmunoassay supplied?

  The device is supplied as an in vitro assay kit for laboratory use. It contains all necessary components for performing the quantitative measurement of hCG in serum or plasma specimens according to the manufacturer's instructions.

• What is the regulatory status of the CA-1511 Radioimmunoassay?

  The CA-1511 received FDA 510(k) clearance (K841821) on June 22, 1984, and is classified as a Class II medical device under FDA regulation 862.1155. It is substantially equivalent to a legally marketed predicate device.

• What is the intended use of the CA-1511 test system?

  The CA-1511 is intended for the quantitative measurement of human chorionic gonadotropin (hCG) in serum or plasma specimens. This measurement is typically used in clinical settings for various diagnostic purposes related to pregnancy and other conditions.