The following data is part of a premarket notification filed by Wako Pure Chemical Industries, Ltd. with the FDA for Ammonia Test.
| Device ID | K813366 |
| 510k Number | K813366 |
| Device Name: | AMMONIA TEST |
| Classification | Photometric Method, Ammonia |
| Applicant | WAKO PURE CHEMICAL INDUSTRIES, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JID |
| CFR Regulation Number | 862.1065 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-30 |
| Decision Date | 1981-12-22 |