Xn Check
by Streck 3 variants
510(k) K120742
Xn Check is a Class II device made by Streck, cleared under FDA 510(k) K120742 on 19 Oct 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120742 | Date19 Oct 2012 | StatusActive |
Official records
- FDA 510(k) database K120742
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- Withdrawn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
Similar devices
Other devices filed under FDA product code JPK (Mixture, Hematology Quality Control).
- RETIC-CHEX by Streck Laboratories, Inc.
- TECHNICON TEST POINT ASSAYED HEMATOLOGY by Technicon Instruments Corp.
- LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II by Bio-Rad
- TRI-COUNT 10 by Hematology Marketing Assoc.
- PLATELET-CHEX-HUMAN by Streck Laboratories, Inc.
- COULTER ACT TRON CELL CONTROL by Coulter Corp.
- CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 by R&D Systems, Inc.
- DIA T1, T2 & T3 by Diatech, Inc.
- PLATELET CONTROL by Bhp Diagnostix, Inc.
- Research and Diagnostic Systems CT001 by RESEARCH AND DIAGNOSTIC SYSTEMS, INC.