The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Calcium-arsenazo Iii Reagent Set.
| Device ID | K921625 |
| 510k Number | K921625 |
| Device Name: | CALCIUM-ARSENAZO III REAGENT SET |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters |
| Correspondent | William F Walters POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | CIC |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-06 |
| Decision Date | 1992-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014061 | K921625 | 000 |
| 00811727014054 | K921625 | 000 |
| 00811727013484 | K921625 | 000 |
| 00811727010643 | K921625 | 000 |
| 00811727010636 | K921625 | 000 |
| 00811727010629 | K921625 | 000 |
| 00811727015754 | K921625 | 000 |
| 00850053916076 | K921625 | 000 |