Sickle Cell Reagent Set
FDA 510(k) K860420 · Sterling Diagnostics, Inc.
510(k) numberK860420
Submission
- Device name
- Sickle Cell Reagent Set
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- February 4, 1986
- Decision date
- February 24, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K960947 | SAS Sickle Cell TestGHM · Traditional | Sa Scientific, Inc. | 07/01/1996SE |
| 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 |
| 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 |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was Sickle Cell Reagent Set cleared by the FDA?
Sickle Cell Reagent Set (K860420) received a 510(k) decision of Substantially Equivalent on February 24, 1986, 20 days after the submission was received.
What is the product code of K860420?
The FDA product code is GHM – Test, Sickle Cell, a Class II (moderate risk) device regulated under 21 CFR 864.7825.