The following data is part of a premarket notification filed by The Binding Site with the FDA for Human Igd Kit For Use On Spaplus.
| Device ID | K092450 |
| 510k Number | K092450 |
| Device Name: | HUMAN IGD KIT FOR USE ON SPAPLUS |
| Classification | Igd, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE 12100 WILSHIRE BLVD SUITE 500 Los Angeles, CA 90025 |
| Contact | Jay Geller |
| Correspondent | Jay Geller THE BINDING SITE 12100 WILSHIRE BLVD SUITE 500 Los Angeles, CA 90025 |
| Product Code | CZJ |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-10 |
| Decision Date | 2009-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017572 | K092450 | 000 |
| 05051700012348 | K092450 | 000 |