The following data is part of a premarket notification filed by Hichem Diagnostics with the FDA for Hi Chem Inorganic Phosphorus Reagent Kit #88196.
| Device ID | K890773 |
| 510k Number | K890773 |
| Device Name: | HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196 |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Contact | Ralph Bolstad |
| Correspondent | Ralph Bolstad HICHEM DIAGNOSTICS 231 N. PUENTE ST. Brea, CA 92621 |
| Product Code | CEO |
| CFR Regulation Number | 862.1580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-15 |
| Decision Date | 1989-04-18 |