The following data is part of a premarket notification filed by The Binding Site, Ltd. with the FDA for Caeruloplasmin Immunological Nl Test Kit.
| Device ID | K913668 |
| 510k Number | K913668 |
| Device Name: | CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT |
| Classification | Ceruloplasmin, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller THE BINDING SITE, LTD. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Product Code | DDB |
| CFR Regulation Number | 866.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-19 |
| Decision Date | 1991-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700010719 | K913668 | 000 |