The following data is part of a premarket notification filed by Dms Laboratories with the FDA for Trp.
Device ID | K831187 |
510k Number | K831187 |
Device Name: | TRP |
Classification | Discs, Strips And Reagents, Microorganism Differentiation |
Applicant | DMS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTO |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-04-12 |
Decision Date | 1983-05-09 |