The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Cresolphthalein Complexone, Calcium.
| Device ID | K874131 |
| 510k Number | K874131 |
| Device Name: | CRESOLPHTHALEIN COMPLEXONE, CALCIUM |
| Classification | Cresolphthalein Complexone, Calcium |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | F Walters,jr |
| Correspondent | F Walters,jr 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 | 1987-10-13 |
| Decision Date | 1987-12-04 |