The following data is part of a premarket notification filed by Dms Laboratories with the FDA for Rapid Strep.
Device ID | K813610 |
510k Number | K813610 |
Device Name: | RAPID STREP |
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 | 1981-12-29 |
Decision Date | 1982-02-04 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RAPID STREP 74677901 not registered Dead/Abandoned |
MEDIX BIOTECH, INC. 1995-05-22 |