XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020— 510(k) K031965
Substantially EquivalentRemel, Inc.
FDA 510(k) clearance K031965 for XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020, Substantially Equivalent on 2003-11-14. Applicant: Remel, Inc.. Device class: 2.
Clearance details
- Applicant
- Remel, Inc.
- Product code
- Code MHJ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3220
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ramsey, MN, US
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