ANA-SCREEN WITH MDSS— 510(k) K113610
Substantially EquivalentBio-Rad Laboratories
FDA 510(k) clearance K113610 for ANA-SCREEN WITH MDSS, Substantially Equivalent on 2012-07-09. Applicant: Bio-Rad Laboratories. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories
- Product code
- Code LKJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Benicia, CA, US
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Recalls naming K113610
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113610.
Data sourced from openFDA. This site is unofficial and independent of the FDA.