Hematachek
FDA 510(k) K964452 · Richmond Diagnostics, Inc.
510(k) numberK964452
Submission
- Device name
- Hematachek
- Applicant
- Richmond Diagnostics, Inc.
New Brunswick, NJ, US - Received
- November 6, 1996
- Decision date
- February 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GLK – Control, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code GLK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121467 | Eurotrol Hematocrit ControlGLK · Traditional | Eurotrol B.V. | 05/10/2013SE |
| K021924 | Medica Easyqc Hematocrit ControlGLK · Traditional | Bionostics, Inc. | 06/24/2002SE |
| K020618 | Aalto Scientific Mirco Hematocrit ControlGLK · Traditional | Aalto Scientific, Ltd. | 05/14/2002SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | Ciba Corning Diagnostics Corp. | 07/26/1996SE |
| K924926 | Msi-HctGLK · Traditional | Medical Specialties, Inc. | 01/07/1993SE |
| K893562 | A.Qc HCT Level 1 and 2GLK · Traditional | Johnson & Johnson Professionals, Inc. | 07/14/1989SE |
Questions and answers
When was Hematachek cleared by the FDA?
Hematachek (K964452) received a 510(k) decision of Substantially Equivalent on February 20, 1997, 106 days after the submission was received.
What is the product code of K964452?
The FDA product code is GLK – Control, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.8625.