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 |