The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Psi Calcium Reagent.
| Device ID | K822469 |
| 510k Number | K822469 |
| Device Name: | PSI CALCIUM REAGENT |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| 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 |
|---|---|---|
| 00811727014986 | K822469 | 000 |
| 00817274021088 | K822469 | 000 |
| 00817274021095 | K822469 | 000 |
| 00817274021101 | K822469 | 000 |
| 00817274022559 | K822469 | 000 |
| 00817439020345 | K822469 | 000 |
| 00811727010582 | K822469 | 000 |
| 00811727010599 | K822469 | 000 |
| 00811727010650 | K822469 | 000 |
| 00811727012609 | K822469 | 000 |
| 00811727012968 | K822469 | 000 |
| 00811727013941 | K822469 | 000 |
| 00811727013958 | K822469 | 000 |
| 00811727013965 | K822469 | 000 |
| 00811727014719 | K822469 | 000 |
| 00811727016065 | K822469 | 000 |