The following data is part of a premarket notification filed by Dms Products, Inc. with the FDA for Api 20 Ec (enterobacteriaceae)(identification Kit).
| Device ID | K854733 |
| 510k Number | K854733 |
| Device Name: | API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) |
| Classification | Kit, Identification, Enterobacteriaceae |
| Applicant | DMS PRODUCTS, INC. DART'S MILL PROFESSIONAL VILL. RT. 523, BOX 95 Flemington, NJ 08822 |
| Product Code | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-25 |
| Decision Date | 1986-03-06 |