The following data is part of a premarket notification filed by Miles, Inc. with the FDA for Direct Amylase (ec 3.2.1.1) Method For Technicon Systems.
| Device ID | K933682 |
| 510k Number | K933682 |
| Device Name: | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS |
| Classification | Catalytic Methods, Amylase |
| Applicant | MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Gabriel J Muraca, Jr. |
| Correspondent | Gabriel J Muraca, Jr. MILES, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-29 |
| Decision Date | 1994-04-12 |