Thromboscreen Joshua Hemoglobin S Screening Kit
FDA 510(k) K872217 · Pacific Hemostasis
510(k) numberK872217
Submission
- Device name
- Thromboscreen Joshua Hemoglobin S Screening Kit
- Applicant
- Pacific Hemostasis
Ventura, CA, US - Received
- June 9, 1987
- Decision date
- July 31, 1987
- 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 |
| 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 |
|---|---|---|
| K000679 | Thrombostrate Control PlasmasGGN · Traditional | 03/24/2000SE |
| K994100 | Pacific Hemostasis Thromboplastin DGJS · Traditional | 02/18/2000SE |
| K992130 | Pacific Hemostasis Thromboscreen 400CKQG · Traditional | 09/03/1999SE |
| K992279 | Heparin Control Plasma Level 2GGN · Traditional | 08/26/1999SE |
| K992278 | Heparin Control Plasma Level 1GGN · Traditional | 08/26/1999SE |
| K991321 | Pacific Hemostasis Thromboscreen 200KQG · Traditional | 06/21/1999SE |
| K990046 | Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaGJT · Traditional | 02/17/1999SE |
| K984131 | Coagulation Control Level 3 (Abnormal)GGC · Traditional | 12/01/1998SE |
| K984130 | Coagulation Control Level 2 (Abnormal)GGC · Traditional | 12/01/1998SE |
| K984129 | Coagulation Control Level 1 (Normal)GIZ · Traditional | 12/01/1998SE |
Questions and answers
When was Thromboscreen Joshua Hemoglobin S Screening Kit cleared by the FDA?
Thromboscreen Joshua Hemoglobin S Screening Kit (K872217) received a 510(k) decision of Substantially Equivalent on July 31, 1987, 52 days after the submission was received.
What is the product code of K872217?
The FDA product code is GHM – Test, Sickle Cell, a Class II (moderate risk) device regulated under 21 CFR 864.7825.