Cell-Chex
FDA 510(k) K101335 · Streck
510(k) numberK101335
Submission
- Device name
- Cell-Chex
- Applicant
- Streck
La Vista, NE, US - Received
- May 12, 2010
- Decision date
- August 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GLQ – Mixture, Control, White-Cell And Red-Cell Indices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111211 | Cell-Dyn 22 Plus ControlGLQ · Traditional | Streck | 12/22/2011SE |
| K110718 | Cell-Chex with CPPD CrystalsGLQ · Traditional | Streck | 05/26/2011SE |
| K090137 | Stak-Chex Plus ReticsGLQ · Traditional | Streck | 03/18/2009SE |
| K000945 | Para 12 Plus ReticsGLQ · Traditional | Streck Laboratories, Inc. | 04/18/2000SE |
| K994388 | Xe CheckGLQ · Traditional | Streck Laboratories, Inc. | 01/14/2000SE |
| K992887 | Stak-Chex Plus ReticsGLQ · Traditional | Streck Laboratories, Inc. | 11/22/1999SE |
| K823794 | Control TM 8GLQ · Traditional | General Diagnostics | 01/14/1983SE |
| K823587 | Uni-CellGLQ · Traditional | Medical Specialties Laboratories | 01/05/1983SE |
| K823498 | Para 12GLQ · Traditional | Streck Laboratories, Inc. | 12/28/1982SE |
More from Streck Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260041 | MDx-Chex for BCPPMN · Traditional | 03/27/2026SE |
| K254166 | MDx-Chex for BCNPMN · Traditional | 03/23/2026SE |
| K254167 | MDx-Chex for BCYPMN · Traditional | 03/17/2026SE |
| K231776 | Cell-Free DNA BCTQMA · Traditional | 07/26/2024SE |
| K231223 | MDx-Chex for BC-GNPMN · Traditional | 07/27/2023SE |
| K231221 | MDx-Chex for BC-GPPMN · Traditional | 07/27/2023SE |
| K212576 | MDx-Chex for BCID2PMN · Traditional | 01/19/2022SE |
| K170091 | UA-Cellular CompleteJJW · Traditional | 02/09/2017SE |
| K160590 | XN CheckJPK · Traditional | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | 12/22/2016SE |
Questions and answers
When was Cell-Chex cleared by the FDA?
Cell-Chex (K101335) received a 510(k) decision of Substantially Equivalent on August 23, 2010, 103 days after the submission was received.
What is the product code of K101335?
The FDA product code is GLQ – Mixture, Control, White-Cell And Red-Cell Indices, a Class II (moderate risk) device regulated under 21 CFR 864.8625.