The following data is part of a premarket notification filed by Wako Chemicals, Usa, Inc. with the FDA for Wako Nefa C Test.
| Device ID | K812081 |
| 510k Number | K812081 |
| Device Name: | WAKO NEFA C TEST |
| Classification | Conversion To Ferric Hydroxymates (colorimetric), Fatty Acids |
| Applicant | WAKO CHEMICALS, USA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JLG |
| CFR Regulation Number | 862.1290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-22 |
| Decision Date | 1981-08-12 |