The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Carbon Dioxide Reagent.
| Device ID | K896812 |
| 510k Number | K896812 |
| Device Name: | CARBON DIOXIDE REAGENT |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | F Walters |
| Correspondent | F Walters POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-02-23 |