SAS Sickle Cell Test
FDA 510(k) K960947 · Sa Scientific, Inc.
510(k) numberK960947
Submission
- Device name
- SAS Sickle Cell Test
- Applicant
- Sa Scientific, Inc.
San Antonio, TX, US - Received
- March 8, 1996
- Decision date
- July 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GHM – Test, Sickle Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7825
- Specialty
- Hematology
Other 510(k)s with product code GHM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | Streck Laboratories, Inc. | 12/30/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | Streck Laboratories, Inc. | 11/06/2001SE |
| K911981 | Hemocard Hemoglobin SGHM · Traditional | Isolab, Inc. | 10/09/1991SE |
| K910430 | Hemocard-AsGHM · Traditional | Isolab, Inc. | 04/15/1991SE |
| K872217 | Thromboscreen Joshua Hemoglobin S Screening KitGHM · Traditional | Pacific Hemostasis | 07/31/1987SE |
| K860812 | Sickle Cell Reagent SetGHM · Traditional | Michclone Associates, Inc. | 04/11/1986SE |
| K860420 | Sickle Cell Reagent SetGHM · Traditional | Sterling Diagnostics, Inc. | 02/24/1986SE |
| K854079 | Thrombo Screen Sickle Cell Assay SetGHM · Traditional | Pacific Hemostasis | 10/31/1985SE |
| K842152 | Sickling Hemoglobin Controls, NormalGHM · Traditional | Isolab, Inc. | 09/09/1984SE |
| K842955 | Sickle-Heme A/S Heterozygous ControlGHM · Traditional | Michclone Associates, Inc. | 08/09/1984SE |
More from Michclone Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K132352 | SAS Flualert a & B, SAS Influenza a TestGNX · Special | 08/22/2013SE |
| K100227 | SAS Flualert A&B, SAS Influenza a TestPSZ · Special | 02/23/2010SE |
| K080380 | SAS Influenza a & B TestPSZ · Traditional | 07/23/2009SE |
| K061496 | SAS Legionella Test, SAS Legionella Dipstick TestMJH · Traditional | 06/28/2007SE |
| K041441 | SAS Influenza a TestPSZ · Traditional | 07/22/2004SE |
| K041439 | SAS Influenza B TestPSZ · Traditional | 07/22/2004SE |
| K030628 | SAS RSV Control KitJJX · Traditional | 03/17/2003SE |
| K022845 | SAS RSV TestGQG · Traditional | 01/29/2003SE |
| K022683 | SAS Blood/Serum/Urine/Urine HCGJHI · Traditional | 12/16/2002SE |
| K023270 | SAS StrepalertGTY · Traditional | 10/17/2002SE |
Questions and answers
When was SAS Sickle Cell Test cleared by the FDA?
SAS Sickle Cell Test (K960947) received a 510(k) decision of Substantially Equivalent on July 1, 1996, 115 days after the submission was received.
What is the product code of K960947?
The FDA product code is GHM – Test, Sickle Cell, a Class II (moderate risk) device regulated under 21 CFR 864.7825.