Bindazyme ANTI-B2 Screen Eia Test Kit.
FDA 510(k) K991804 · The Binding Site, Ltd.
510(k) numberK991804
Submission
- Device name
- Bindazyme ANTI-B2 Screen Eia Test Kit.
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- May 26, 1999
- Decision date
- May 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
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Questions and answers
When was Bindazyme ANTI-B2 Screen Eia Test Kit. cleared by the FDA?
Bindazyme ANTI-B2 Screen Eia Test Kit. (K991804) received a 510(k) decision of Substantially Equivalent on May 5, 2000, 345 days after the submission was received.
What is the product code of K991804?
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.