Autostat II ANTI-B-2 Glycoprotein I Igg Elisa
FDA 510(k) K022945 · Hycor Biomedical, Inc.
510(k) numberK022945
Submission
- Device name
- Autostat II ANTI-B-2 Glycoprotein I Igg Elisa
- Applicant
- Hycor Biomedical, Inc.
Garden Grove, CA, US - Received
- September 5, 2002
- Decision date
- December 18, 2002
- 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 Autostat II ANTI-B-2 Glycoprotein I Igg Elisa cleared by the FDA?
Autostat II ANTI-B-2 Glycoprotein I Igg Elisa (K022945) received a 510(k) decision of Substantially Equivalent on December 18, 2002, 104 days after the submission was received.
What is the product code of K022945?
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.