Sickle Cell Reagent Set
FDA 510(k) K860812 · Michclone Associates, Inc.
510(k) numberK860812
Submission
- Device name
- Sickle Cell Reagent Set
- Applicant
- Michclone Associates, Inc.
Detroit, MI, US - Received
- March 4, 1986
- Decision date
- April 11, 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 |
| 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.
Questions and answers
When was Sickle Cell Reagent Set cleared by the FDA?
Sickle Cell Reagent Set (K860812) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 38 days after the submission was received.
What is the product code of K860812?
The FDA product code is GHM – Test, Sickle Cell, a Class II (moderate risk) device regulated under 21 CFR 864.7825.