The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Fast 340 Phosphorous Procedure.
| Device ID | K800297 |
| 510k Number | K800297 |
| Device Name: | SANDARE FAST 340 PHOSPHOROUS PROCEDURE |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | SANDARE CHEMICAL CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-11 |
| Decision Date | 1980-03-05 |