Aeskulska BETA2-GLYCO-A
FDA 510(k) K062217 · Aesku, Inc.
510(k) numberK062217
Submission
- Device name
- Aeskulska BETA2-GLYCO-A
- Applicant
- Aesku, Inc.
Miami, FL, US - Received
- August 1, 2006
- Decision date
- December 13, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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Questions and answers
When was Aeskulska BETA2-GLYCO-A cleared by the FDA?
Aeskulska BETA2-GLYCO-A (K062217) received a 510(k) decision of Substantially Equivalent on December 13, 2006, 134 days after the submission was received.
What is the product code of K062217?
The FDA product code is MSV – System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi), a Class II (moderate risk) device regulated under 21 CFR 866.5660.