FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K Number: K031942
·
Decision Nov 18, 2003
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
26
Applicant Total
17
Review Days
147
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Basic Information
- Device Name
- XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
- K Number
- K031942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Remel, Inc.
- Date Received
- June 24, 2003
- Decision Date
- November 18, 2003
- Product Code
- MHI
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHI | Giardia Spp. | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHI), ordered by most recent decision date.
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GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
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IVD CRYPTO/GIARDIA DFA
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| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | Nov 14, 2003 | Substantially Equivalent |
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