The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Rapid Yeast Plus System.
Device ID | K943621 |
510k Number | K943621 |
Device Name: | RAPID YEAST PLUS SYSTEM |
Classification | Kit, Identification, Yeast |
Applicant | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
Contact | Louis A Eriquez, Ph.d. |
Correspondent | Louis A Eriquez, Ph.d. INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
Product Code | JXB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-27 |
Decision Date | 1995-01-27 |