Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls
FDA 510(k) K091556 · Instrumentation Laboratory CO
510(k) numberK091556
Submission
- Device name
- Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- May 27, 2009
- Decision date
- May 21, 2010
- 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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| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | Immco Diagnostics, Inc. | 06/19/2017SE |
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| K092757 | Theratest EL-BETA2GPI (Igm-Igg-Iga), Theratest EL--BETA2GPI SCRMSV · Special | Thera-Test Laboratories, Inc. | 10/09/2009SE |
| K072032 | Igg Anti-Atherox Test KitMSV · Traditional | Corgenix, Inc. | 04/04/2008SE |
| K062217 | Aeskulska BETA2-GLYCO-AMSV · Traditional | Aesku, Inc. | 12/13/2006SE |
| K040452 | Varelisa B2 Glycoprotein I Antibodies Screen, Models 19048 and 19096MSV · Traditional | Pharmacia Deutschland GmbH | 05/11/2004SE |
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Questions and answers
When was Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls cleared by the FDA?
Hemosil Acustar ANTI-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls (K091556) received a 510(k) decision of Substantially Equivalent on May 21, 2010, 359 days after the submission was received.
What is the product code of K091556?
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.