Ana-Screen with MDSS
FDA 510(k) K113610 · Bio-Rad Laboratories
510(k) numberK113610
Submission
- Device name
- Ana-Screen with MDSS
- Applicant
- Bio-Rad Laboratories
Benicia, CA, US - Received
- December 6, 2011
- Decision date
- July 9, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LKJ – Antinuclear Antibody, Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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Questions and answers
When was Ana-Screen with MDSS cleared by the FDA?
Ana-Screen with MDSS (K113610) received a 510(k) decision of Substantially Equivalent on July 9, 2012, 216 days after the submission was received.
What is the product code of K113610?
The FDA product code is LKJ – Antinuclear Antibody, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.