The following data is part of a premarket notification filed by Janssen Research Foundation with the FDA for Elisa Combi-kit Human Igg Subclasses.
| Device ID | K911610 |
| 510k Number | K911610 |
| Device Name: | ELISA COMBI-KIT HUMAN IGG SUBCLASSES |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | JANSSEN RESEARCH FOUNDATION 40 KINGSBRIDGE RD. Piscataway, NJ 08555 |
| Contact | Ruth Wasserman |
| Correspondent | Ruth Wasserman JANSSEN RESEARCH FOUNDATION 40 KINGSBRIDGE RD. Piscataway, NJ 08555 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-06-12 |