The following data is part of a premarket notification filed by Intersect Systems, Inc. with the FDA for Intersect Systems Direct Amylase Reagent.
| Device ID | K932888 |
| 510k Number | K932888 |
| Device Name: | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT |
| Classification | Catalytic Methods, Amylase |
| 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 | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1994-01-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851445007044 | K932888 | 000 |