The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Neisseria/branhamella Differential Test.
| Device ID | K870117 |
| 510k Number | K870117 |
| Device Name: | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST |
| Classification | Kit, Identification, Neisseria Gonorrhoeae |
| Applicant | PRO-LAB, INC. 705 PROGRESS AVE UNIT 3A Scarborough Ont, CA |
| Contact | Lynn Rae |
| Correspondent | Lynn Rae PRO-LAB, INC. 705 PROGRESS AVE UNIT 3A Scarborough Ont, CA |
| Product Code | JSX |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-12 |
| Decision Date | 1987-03-20 |