Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets
FDA 510(k) K103834 · Bio-Rad Laboratories
510(k) numberK103834
Submission
- Device name
- Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets
- Applicant
- Bio-Rad Laboratories
Benicia, CA, US - Received
- December 30, 2010
- Decision date
- March 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MID – System, Test, Anticardiolipin Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID · Traditional | Inova Diagnostics, Inc. | 12/17/2024SE |
| K131821 | Elia(Tm) Cardiolipin Iga ImmunoassayMID · Traditional | Phadia US, Inc. | 12/23/2013SE |
| K130528 | Bioplex 2200 Apls IgmMID · Traditional | Bio-Rad Laboratories | 10/21/2013SE |
| K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaMID · Traditional | Inova Diagnostics, Inc. | 02/26/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | Immco Diagnostics, Inc. | 10/25/2012SE |
| K102425 | Zeus Elisa Cardiolipin Igg/Igm/Iga Test SystemMID · Traditional | Zeus Scientific, Inc. | 12/12/2011SE |
| K091845 | Cardiolipin Autoantibody Immunological Test SystemMID · Traditional | Phadia US, Inc. | 06/07/2010SE |
| K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsMID · Traditional | Instrumentation Laboratory CO | 03/11/2010SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | Theratest Laboratories, Inc. | 02/07/2006SE |
| K040463 | Aeskulisa Cardiolipin AgmMID · Traditional | Aesku, Inc. | 05/12/2004SE |
More from Aesku, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183446 | BioPlex 2200 Lyme TotalLSR · Traditional | 03/12/2019SE |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX · Traditional | 02/13/2019SE |
| K180577 | BioPlex 2200 25-OH Vitamin D KitMRG · Traditional | 06/22/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | 09/13/2017SE |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…PUQ · Traditional | 05/19/2017SE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional | 05/11/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | 01/10/2017SE |
| K161687 | D-10 Hemoglobin A1c ProgramPDJ · Traditional | 10/14/2016SE |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level…PMN · Traditional | 05/10/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | 12/11/2015SE |
Questions and answers
When was Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets cleared by the FDA?
Bioplex 2200 Apls Igg and Iga Kit and Calibrator and Control Sets (K103834) received a 510(k) decision of Substantially Equivalent on March 30, 2012, 456 days after the submission was received.
What is the product code of K103834?
The FDA product code is MID – System, Test, Anticardiolipin Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5660.