FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CL DETECT RAPID TEST
K Number: K141341
·
Decision Nov 14, 2014
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
7
Review Days
177
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Basic Information
- Device Name
- CL DETECT RAPID TEST
- K Number
- K141341
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3870
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- InBios International, Inc.
- Date Received
- May 21, 2014
- Decision Date
- November 14, 2014
- Product Code
- PIT
- 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 |
|---|---|---|---|
| PIT | Leishmania Spp. Antigen Detection Assay | FDA class 1 | Microbiology |
Other Clearances by InBios International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251595 | COVID-19 Detect Rapid Self -Test | Oct 12, 2025 | Substantially Equivalent |
| K233358 | SCoV-2 Ag Detect Rapid Test | Aug 23, 2024 | Substantially Equivalent |
| DEN220044 | Active Anthrax DetectTM Plus Rapid Test | Feb 3, 2023 | Unknown |
| DEN180069 | ZIKV Detect 2.0 IgM Capture ELISA | May 23, 2019 | Unknown |
| K181473 | DENV Detect NS1 ELISA | Aug 27, 2018 | Substantially Equivalent |
| K161947 | Chagas Detect Plus Rapid Test | Dec 16, 2016 | Substantially Equivalent |