The following data is part of a premarket notification filed by Dms Products, Inc. with the FDA for Rapidec Staph.
| Device ID | K891004 |
| 510k Number | K891004 |
| Device Name: | RAPIDEC STAPH |
| Classification | Gram Positive Identification Panel |
| Applicant | DMS PRODUCTS, INC. DART'S MILL PROFESSIONAL VILL. RT. 523, BOX 95 Flemington, NJ 08822 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone DMS PRODUCTS, INC. DART'S MILL PROFESSIONAL VILL. RT. 523, BOX 95 Flemington, NJ 08822 |
| Product Code | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-28 |
| Decision Date | 1989-11-09 |