The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Ids Rapids Nh Systems.
| Device ID | K812048 |
| 510k Number | K812048 |
| Device Name: | IDS RAPIDS NH SYSTEMS |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-20 |
| Decision Date | 1981-08-18 |