Panels › Immunology › Product code NSF · Class 2
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Regulation 866.6030
0510(k)s in 12 months (2 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NSF
| Company | 510(k)s | Recalls |
|---|---|---|
| Wako Chemicals USA, Inc. | 2 | 0 |
| Fujifilm Medical Systems U.S.A., Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2011 | K100464 | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION Wako Chemicals USA, Inc. | NSF |
| May 19, 2005 | DEN050002 | LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS Wako Chemicals USA, Inc. | NSF |
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