The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Ultrachem Phos.
Device ID | K821874 |
510k Number | K821874 |
Device Name: | ULTRACHEM PHOS |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
Applicant | HARLECO DIAGNOSTICS 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 | 1982-06-25 |
Decision Date | 1982-07-13 |