The following data is part of a premarket notification filed by Innovative Diagnostic Systems, Inc. with the FDA for Modified Ids Rapid Nh System.
Device ID | K881501 |
510k Number | K881501 |
Device Name: | MODIFIED IDS RAPID NH SYSTEM |
Classification | Kit, Identification, Neisseria Gonorrhoeae |
Applicant | INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
Contact | Louis A Eriquez,phd |
Correspondent | Louis A Eriquez,phd INNOVATIVE DIAGNOSTIC SYSTEMS, INC. 3404 OAKCLIFF RD. #C-1 Atlanta, GA 30340 |
Product Code | JSX |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-11 |
Decision Date | 1988-05-18 |