The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Enzymatic Co2 Reagent, Modification.
| Device ID | K932267 |
| 510k Number | K932267 |
| Device Name: | ENZYMATIC CO2 REAGENT, MODIFICATION |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E P.O. BOX 2219 Longview, WA 98632 |
| Contact | Taras Tatarko |
| Correspondent | Taras Tatarko INTERSECT SYSTEMS, INC. 1152 3RD AVE., SUITE D/E P.O. BOX 2219 Longview, WA 98632 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-14 |
| Decision Date | 1993-09-24 |