The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Carbon Dioxide Reagent.
Device ID | K881169 |
510k Number | K881169 |
Device Name: | CARBON DIOXIDE REAGENT |
Classification | Enzymatic, Carbon-dioxide |
Applicant | INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 Longview, WA 98632 |
Contact | Lester B Garrison |
Correspondent | Lester B Garrison INTERSECT SYSTEMS, INC. 1606 E. KESSLER BLVD., #100 P.O. BOX 889 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 | 1988-03-18 |
Decision Date | 1988-04-28 |