The following data is part of a premarket notification filed by Sanquin Blood Supply Foundation with the FDA for Peliclass Human Igg Subclass Nephelometric Immage Kit.
| Device ID | K020823 |
| 510k Number | K020823 |
| Device Name: | PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT |
| Classification | Igg (gamma Chain Specific), Antigen, Antiserum, Control |
| Applicant | SANQUIN BLOOD SUPPLY FOUNDATION 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SANQUIN BLOOD SUPPLY FOUNDATION 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | DFZ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-14 |
| Decision Date | 2002-05-14 |
| Summary: | summary |