BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
FDA 510(k) K170509 · Bio-Rad Laboratories
510(k) numberK170509
Submission
- Device name
- BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- Applicant
- Bio-Rad Laboratories
Benicia, CA, US - Received
- February 21, 2017
- Decision date
- May 19, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PUQ – Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Specialty
- Microbiology
The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.
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Questions and answers
When was BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set cleared by the FDA?
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (K170509) received a 510(k) decision of Substantially Equivalent on May 19, 2017, 87 days after the submission was received.
What is the product code of K170509?
The FDA product code is PUQ – Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm, a Class II (moderate risk) device regulated under 21 CFR 866.3510.