Aburia-Ck Ria Test Kit
by Intl. Immunoassay Laboratories, Inc. 510(k)
Active
510(k) K813087
Overview
The Aburia-Ck Ria Test Kit is a fluorometric method device used for measuring Cpk or isoenzymes in clinical chemistry applications. This test kit is designed for laboratory use and provides analytical measurements for clinical chemistry purposes.
The device is supplied by Intl. Immunoassay Laboratories, Inc. and is a Class 2 medical device. It has FDA 510(k) clearance with number K813087, received on November 2, 1981, and cleared on December 17, 1981. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813087 | Date17 Dec 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1215
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Intl. Immunoassay Laboratories, Inc.
Questions
What is the Aburia-Ck Ria Test Kit used for?
The Aburia-Ck Ria Test Kit is a fluorometric method device designed for measuring Cpk or isoenzymes in clinical chemistry applications. It is intended for laboratory use to provide analytical measurements for clinical chemistry purposes.
Is the Aburia-Ck Ria Test Kit single-use or reusable?
The device is not specified as single-use or reusable in the provided information. No details regarding sterility, MRI safety, or storage conditions are available in the device data.
What is the regulatory status of the Aburia-Ck Ria Test Kit?
The Aburia-Ck Ria Test Kit is a Class 2 medical device with FDA 510(k) clearance number K813087. It received clearance on December 17, 1981, and was determined to be substantially equivalent to predicate devices in clinical chemistry applications.
Who manufactures the Aburia-Ck Ria Test Kit?
The Aburia-Ck Ria Test Kit is manufactured by Intl. Immunoassay Laboratories, Inc., located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States. The company has multiple FEI numbers associated with this device.