Retic Chex Linearity
510(k) K000115
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000115 | Date27 Mar 2000 | 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- Withdrawn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
- JPK
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8625
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
This device is a hematology quality control mixture used for verifying reticulocyte parameter accuracy on automated hematology systems. It is designed to establish the reportable range and linearity of analyzers that measure reticulocytes.
Supplied as a 5 x 3 mL kit, it is intended for routine maintenance, quality control procedures, calibration, and precision checks according to laboratory protocol. The product has received FDA 510(k) clearance under product code JPK and regulation number 864.8625, and is classified as a Class II device in hematology.
Other devices from Streck Laboratories, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the RETIC CHEX LINEARITY used for?
It is used to verify reticulocyte parameter accuracy and establish the reportable range and linearity of automated hematology systems that measure reticulocytes, supporting routine maintenance, quality control, calibration, and precision checks per laboratory protocol.
How is the RETIC CHEX LINEARITY supplied and stored?
It is supplied as a kit containing five 3 mL vials, totaling 15 mL, and should be stored according to the manufacturer's instructions for use to maintain stability and performance for quality control procedures.
Is the RETIC CHEX LINEARITY intended for single-use or multiple uses?
As a hematology quality control mixture, each vial is intended for single-use per testing session to prevent contamination and ensure reliable results, consistent with standard QC practices for liquid controls in clinical laboratories.