The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Ra System, Analyte Serum Amylase (30c And 37c).
| Device ID | K871269 |
| 510k Number | K871269 |
| Device Name: | RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) |
| Classification | Catalytic Methods, 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 | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-31 |
| Decision Date | 1987-04-13 |