Cell-Chex
FDA 510(k) K000076 · Streck Laboratories, Inc.
510(k) numberK000076
Submission
- Device name
- Cell-Chex
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- January 10, 2000
- Decision date
- March 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJR – Control, Red-Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080016 | Nrbc-Chex for AdviaGJR · Traditional | Streck | 02/05/2008SE |
| K060083 | Nrbc-Chex for LHGJR · Traditional | Streck | 02/09/2006SE |
| K940430 | SedratrolGJR · Traditional | Medical Specialties Intl., Inc. | 02/06/1995SE |
| K900484 | Ret-CheckGJR · Traditional | Streck Laboratories, Inc. | 03/09/1990SE |
More from Streck Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042587 | Retic-Chex for Cell-DynJPK · Traditional | 10/19/2004SE |
| K040107 | Cyto-Chex BCTJKA · Traditional | 07/27/2004SE |
| K040025 | A1C-CELLULARJJX · Traditional | 03/02/2004SE |
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | 12/30/2002SE |
| K021922 | Modification to Para 5XJPK · Special | 06/25/2002SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | 04/04/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | 11/06/2001SE |
| K011410 | Para 5XJPK · Traditional | 06/26/2001SE |
| K001443 | Sugar Chex OneJJX · Traditional | 06/29/2000SE |
| K000945 | Para 12 Plus ReticsGLQ · Traditional | 04/18/2000SE |
Questions and answers
When was Cell-Chex cleared by the FDA?
Cell-Chex (K000076) received a 510(k) decision of Substantially Equivalent on March 3, 2000, 53 days after the submission was received.
What is the product code of K000076?
The FDA product code is GJR – Control, Red-Cell, a Class II (moderate risk) device regulated under 21 CFR 864.8625.