The following data is part of a premarket notification filed by Wako Chemicals Usa, Inc. with the FDA for Utaswako I30 (includes Accessories), Utaswako Afp-l3, Calibrator Set, Control L, Control H, Sample Dilution.
| Device ID | K100464 |
| 510k Number | K100464 |
| Device Name: | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION |
| Classification | Test, Alpha Fetoprotein L3 Subfraction (afp-l3%), For Hepatocellular Carcinoma Risk Assessment |
| Applicant | WAKO CHEMICALS USA, INC. 1025 TERRA BELLA AVE SUITE A Mountain View, CA 94043 |
| Contact | Martha Murari |
| Correspondent | Martha Murari WAKO CHEMICALS USA, INC. 1025 TERRA BELLA AVE SUITE A Mountain View, CA 94043 |
| Product Code | NSF |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | OAU |
| Subsequent Product Code | OUE |
| CFR Regulation Number | 866.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-18 |
| Decision Date | 2011-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00085662006168 | K100464 | 000 |
| 04987481164499 | K100464 | 000 |
| 04987481164482 | K100464 | 000 |
| 04987481164468 | K100464 | 000 |
| 04987481164451 | K100464 | 000 |
| 04987481164444 | K100464 | 000 |
| 04987481164420 | K100464 | 000 |
| 04987481164680 | K100464 | 000 |
| 04987481164475 | K100464 | 000 |
| 04987481164437 | K100464 | 000 |
| 04987481164413 | K100464 | 000 |
| 04987481164505 | K100464 | 000 |
| 00856626006229 | K100464 | 000 |
| 10856626006059 | K100464 | 000 |
| 00856626006212 | K100464 | 000 |
| 00856626006205 | K100464 | 000 |
| 00856626006120 | K100464 | 000 |
| 00856626006168 | K100464 | 000 |
| 10856626006189 | K100464 | 000 |
| 10856626006172 | K100464 | 000 |
| 10856626006134 | K100464 | 000 |
| 10856626006080 | K100464 | 000 |
| 10856626006073 | K100464 | 000 |
| 10856626006066 | K100464 | 000 |
| 04987481164390 | K100464 | 000 |