The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Psi Inorganic Phosphorus.
| Device ID | K822470 |
| 510k Number | K822470 |
| Device Name: | PSI INORGANIC PHOSPHORUS |
| Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
| Applicant | POINTE SCIENTIFIC, 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 | 1982-08-17 |
| Decision Date | 1982-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727015105 | K822470 | 000 |
| 00811727016249 | K822470 | 000 |
| 00817439021168 | K822470 | 000 |
| 00817439021182 | K822470 | 000 |
| 00811727011947 | K822470 | 000 |
| 00811727011954 | K822470 | 000 |
| 00811727011961 | K822470 | 000 |
| 00811727011978 | K822470 | 000 |
| 00811727012760 | K822470 | 000 |
| 00811727013095 | K822470 | 000 |
| 00811727013644 | K822470 | 000 |
| 00811727014818 | K822470 | 000 |
| 00811727015945 | K822470 | 000 |