Aalto Scientific Mirco Hematocrit Control
FDA 510(k) K020618 · Aalto Scientific, Ltd.
510(k) numberK020618
Submission
- Device name
- Aalto Scientific Mirco Hematocrit Control
- Applicant
- Aalto Scientific, Ltd.
Carlsbad, CA, US - Received
- February 25, 2002
- Decision date
- May 14, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GLK – Control, Hematocrit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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| K121467 | Eurotrol Hematocrit ControlGLK · Traditional | Eurotrol B.V. | 05/10/2013SE |
| K021924 | Medica Easyqc Hematocrit ControlGLK · Traditional | Bionostics, Inc. | 06/24/2002SE |
| K964452 | HematachekGLK · Traditional | Richmond Diagnostics, Inc. | 02/20/1997SE |
| 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 |
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Questions and answers
When was Aalto Scientific Mirco Hematocrit Control cleared by the FDA?
Aalto Scientific Mirco Hematocrit Control (K020618) received a 510(k) decision of Substantially Equivalent on May 14, 2002, 78 days after the submission was received.
What is the product code of K020618?
The FDA product code is GLK – Control, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.8625.