Hi Chem Calibrator A+
510(k) K895135
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895135 | Date23 Oct 1989 | 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- Withdrawn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, 23 Sep 2026
The Hi Chem Calibrator A+ is a multi-analyte mixture calibrator used in clinical chemistry settings. It is designed to establish reference points for diagnostic testing procedures.
This device is regulated under 21 CFR 862.1150 and received FDA 510(k) clearance under K895135. It is manufactured by Hichem Diagnostics and is intended for professional use in clinical laboratory environments.
Other devices from Hichem Diagnostics
Questions
AI-generated answers, 23 Sep 2026
What is the primary purpose of the Hi Chem Calibrator A+?
This device is a multi-analyte mixture used in clinical chemistry environments to establish reference points for diagnostic testing procedures, ensuring accuracy in laboratory results.
Who is the intended user for this calibrator?
The Hi Chem Calibrator A+ is intended for professional use only within clinical laboratory environments by trained personnel.
Is this device regulated by the FDA?
Yes, the Hi Chem Calibrator A+ is regulated under 21 CFR 862.1150 and received FDA 510(k) clearance under K895135.