510(k) DEN050002
- Device
- LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
- Applicant
- Wako Chemicals USA, Inc.
- 510(k) number
- DEN050002
- Product code
- NSF
- Decision
- Unknown (DENG)
- Decision date
- 2005-05-19
- Date received
- 2005-04-07
- Regulation
- 866.6030
- Classification name
- Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- TONYA MALLORY
- Address
- 1600 Bellwood Rd. Richmond VA US 23237 23237
FDA Registration Numbers#
- 3003522182
- 3003419906
- 2155
- 2020726
- 3005625991
- 2029372
- 3022178699
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NSF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | Wako Chemicals USA, Inc. | 2011-02-23 |