Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System
FDA 510(k) K043341 · Bio-Rad Laboratories, Inc.
510(k) numberK043341
Submission
- Device name
- Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System
- Applicant
- Bio-Rad Laboratories, Inc.
Redmond, WA, US - Received
- December 3, 2004
- Decision date
- October 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NVI – Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
The device is intended to suggest a systemic autoimmune disease association as an aid for differential diagnosis to be evaluated in conjunction with clinical findings and other laboratory tests.
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Questions and answers
When was Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System cleared by the FDA?
Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System (K043341) received a 510(k) decision of Substantially Equivalent on October 27, 2005, 328 days after the submission was received.
What is the product code of K043341?
The FDA product code is NVI – Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease, a Class II (moderate risk) device regulated under 21 CFR 862.3100.