Fastplex BCR-ABL (p210) %IS digital PCR Kit— 510(k) K252243
Substantially EquivalentSuzhou Precigenome, Ltd. Co;
FDA 510(k) clearance K252243 for Fastplex BCR-ABL (p210) %IS digital PCR Kit, Substantially Equivalent on 2026-07-02. Applicant: Suzhou Precigenome, Ltd. Co;. Device class: 2.
Clearance details
- Applicant
- Suzhou Precigenome, Ltd. Co;
- 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
- Suzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.