FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DENV DETECT IGM CAPTURE ELISA
K Number: DEN100020
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
0
Applicant Total
6
Review Days
170
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Basic Information
- Device Name
- DENV DETECT IGM CAPTURE ELISA
- K Number
- DEN100020
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 866.3945
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Inbios Intl., Inc.
- Date Received
- October 20, 2010
- Decision Date
- April 8, 2011
- Product Code
- OSU
- 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 |
|---|---|---|---|
| OSU | Dengue Serological Reagents | FDA class 2 | Microbiology |
Other Clearances by Inbios Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041817 | WEST NILE DETECT IGM ELISA | Nov 19, 2004 | Substantially Equivalent |
| K023483 | KALAZAR DETECT | May 6, 2003 | Substantially Equivalent |
| K001092 | GENERIC BLOOD GLUCOSE TEST STRIP | Jul 26, 2000 | Substantially Equivalent |
| K992695 | INSURE PRO TEST | Oct 18, 1999 | Substantially Equivalent |
| K991515 | INSURE PREGNANCY TEST | May 28, 1999 | Substantially Equivalent |