Medica Easyqc Hematocrit Control
FDA 510(k) K021924 · Bionostics, Inc.
510(k) numberK021924
Submission
- Device name
- Medica Easyqc Hematocrit Control
- Applicant
- Bionostics, Inc.
Devens, MA, US - Received
- June 11, 2002
- Decision date
- June 24, 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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Questions and answers
When was Medica Easyqc Hematocrit Control cleared by the FDA?
Medica Easyqc Hematocrit Control (K021924) received a 510(k) decision of Substantially Equivalent on June 24, 2002, 13 days after the submission was received.
What is the product code of K021924?
The FDA product code is GLK – Control, Hematocrit, a Class II (moderate risk) device regulated under 21 CFR 864.8625.