The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Intersect Systems' Non-mercuric Chloride Reagent.
Device ID | K941807 |
510k Number | K941807 |
Device Name: | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT |
Classification | Acid, Phosphoric-tungstic (spectrophotometric), Chloride |
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 | CHG |
CFR Regulation Number | 862.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-12 |
Decision Date | 1994-09-14 |