Sickle-Chex
FDA 510(k) K852107 · Streck Laboratories, Inc.
510(k) numberK852107
Submission
- Device name
- Sickle-Chex
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- May 15, 1985
- Decision date
- July 5, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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 Sickle-Chex cleared by the FDA?
Sickle-Chex (K852107) received a 510(k) decision of Substantially Equivalent on July 5, 1985, 51 days after the submission was received.