The following data is part of a premarket notification filed by Dms Products, Inc. with the FDA for Rapidec Coli.
Device ID | K890626 |
510k Number | K890626 |
Device Name: | RAPIDEC COLI |
Classification | Kit, Identification, Enterobacteriaceae |
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 | JSS |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-07 |
Decision Date | 1989-06-02 |