The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Amylase,calcium,chloride & Triglycerides On Chem 1.
| Device ID | K863719 |
| 510k Number | K863719 |
| Device Name: | AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 |
| Classification | Saccharogenic, Amylase |
| Applicant | TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Leonard A Dwarica |
| Correspondent | Leonard A Dwarica TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-23 |
| Decision Date | 1986-11-13 |