Calibrator I
510(k) K791693
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791693 | Date17 Sep 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 27 Sep 2026
Calibrator I is a multi-analyte mixture used as a calibrator in clinical chemistry applications. It is designed to provide reference values for diagnostic testing procedures.
This device is regulated as a Class II medical device under FDA 510(k) clearance K791693. It is manufactured by Hi Chem, Inc. and is intended for professional use in clinical laboratory settings.
Other devices from Hi Chem, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the intended use of Calibrator I?
Calibrator I is a multi-analyte mixture designed for use in clinical chemistry applications. Its primary function is to provide reference values for diagnostic testing procedures within professional laboratory settings.
Who is the manufacturer of this device?
This device is manufactured by Hi Chem, Inc., located in McHenry, Illinois.
What is the regulatory status of Calibrator I?
Calibrator I is regulated as a Class II medical device under FDA 510(k) clearance K791693, which indicates it has been found substantially equivalent to other devices in the clinical chemistry category.