Critic-Ars
by Dimension Diagnostics 510(k)
Active
510(k) K844709
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844709 | Date8 Jan 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JIX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Critic-Ars is a Calibrator, Multi-Analyte Mixture, a device used in Clinical Chemistry. It is classified as a device class 2 product. The device has a product code of JIX and is regulated under regulation number 862.1150.
The Critic-Ars is supplied by Dimension Diagnostics and has been authorized with FDA 510K clearance, with a decision date of 1985-01-08. The device is substantially equivalent, as determined by the FDA. The medical specialty for this device is Clinical Chemistry, and it is reviewed by the Clinical Chemistry advisory committee.
Other devices from Dimension Diagnostics
Questions
AI-generated answers, 28 Sep 2026
What is the Critic-Ars used for?
The Critic-Ars is used in clinical chemistry as a calibrator, specifically a multi-analyte mixture.
What is the regulatory status of the Critic-Ars?
The Critic-Ars has been authorized with FDA 510K clearance, determined to be substantially equivalent by the FDA.
What medical specialty is the Critic-Ars associated with?
The Critic-Ars is associated with the medical specialty of Clinical Chemistry, reviewed by the Clinical Chemistry advisory committee.