GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF— 510(k) K081064
Substantially EquivalentIvd Research, Inc.
FDA 510(k) clearance K081064 for GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF, Substantially Equivalent on 2009-01-14. Applicant: Ivd Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Ivd Research, Inc.
- Product code
- Code MHI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3220
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tucson, AZ, US
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