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 |