The following data is part of a premarket notification filed by Janssen Biochimica with the FDA for Human Igg Subclass Rid Kit.
| Device ID | K915650 |
| 510k Number | K915650 |
| Device Name: | HUMAN IGG SUBCLASS RID KIT |
| Classification | Method, Immunodiffusion, Immunoglobulins (g, A, M) |
| Applicant | JANSSEN BIOCHIMICA 40 KINGSBRIDGE RD. Piscataway, NJ 08855 |
| Contact | Ruth Wasserman |
| Correspondent | Ruth Wasserman JANSSEN BIOCHIMICA 40 KINGSBRIDGE RD. Piscataway, NJ 08855 |
| Product Code | CGM |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-18 |
| Decision Date | 1992-03-26 |