QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System— 510(k) K181661
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K181661 for QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System, Substantially Equivalent on 2019-02-13. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code OYX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6060
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
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More clearances from Bio-Rad Laboratories, Inc.
view allRecalls naming K181661
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 K181661.
Data sourced from openFDA. This site is unofficial and independent of the FDA.