The following data is part of a premarket notification filed by Hf Scientific, Inc. with the FDA for Co2 Reagent Set.
| Device ID | K864313 |
| 510k Number | K864313 |
| Device Name: | CO2 REAGENT SET |
| Classification | Volumetric/manometric, Carbon-dioxide |
| Applicant | HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
| Contact | Barbara H Sneade |
| Correspondent | Barbara H Sneade HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
| Product Code | CIE |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-03 |
| Decision Date | 1987-03-13 |