Hemocard Hemoglobin S
FDA 510(k) K911981 · Isolab, Inc.
510(k) numberK911981
Submission
- Device name
- Hemocard Hemoglobin S
- Applicant
- Isolab, Inc.
Akron, OH, US - Received
- May 3, 1991
- Decision date
- October 9, 1991
- 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 |
| K960947 | SAS Sickle Cell TestGHM · Traditional | Sa Scientific, Inc. | 07/01/1996SE |
| 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 |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
Questions and answers
When was Hemocard Hemoglobin S cleared by the FDA?
Hemocard Hemoglobin S (K911981) received a 510(k) decision of Substantially Equivalent on October 9, 1991, 159 days after the submission was received.
What is the product code of K911981?
The FDA product code is GHM – Test, Sickle Cell, a Class II (moderate risk) device regulated under 21 CFR 864.7825.