Cd-Chex CD4 Low
FDA 510(k) K931825 · Streck Laboratories, Inc.
510(k) numberK931825
Submission
- Device name
- Cd-Chex CD4 Low
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- April 6, 1993
- Decision date
- June 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGL – Control, White-Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GGL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K083926 | CD4 CountGGL · Traditional | Streck | 02/11/2009SE |
| K051633 | Cd-Chex Plus BCGGL · Traditional | Streck | 08/16/2005SE |
| K993126 | Cd-Chex CD 34GGL · Traditional | Streck Laboratories, Inc. | 11/26/1999SE |
| K960894 | Cd-Chex + RBCGGL · Traditional | Streck Laboratories, Inc. | 05/24/1996SE |
| K920997 | Cd-ChexGGL · Traditional | Streck Laboratories, Inc. | 05/31/1992SE |
| K894651 | Coulter Positive Control CellsGGL · Traditional | Coulter Corp. | 09/13/1989SE |
| K891175 | Edl Abnormal Coagulation ControlGGL · Traditional | Elite Diagnostic , Ltd. | 04/10/1989SE |
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| K042587 | Retic-Chex for Cell-DynJPK · Traditional | 10/19/2004SE |
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| 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 Cd-Chex CD4 Low cleared by the FDA?
Cd-Chex CD4 Low (K931825) received a 510(k) decision of Substantially Equivalent on June 6, 1994, 426 days after the submission was received.
What is the product code of K931825?
The FDA product code is GGL – Control, White-Cell, a Class II (moderate risk) device regulated under 21 CFR 864.8625.