The following data is part of a premarket notification filed by The Binding Site Group, Ltd. with the FDA for Spaplus.
| Device ID | K100179 |
| 510k Number | K100179 |
| Device Name: | SPAPLUS |
| Classification | Complement C3, Antigen, Antiserum, Control |
| Applicant | THE BINDING SITE GROUP, LTD. Los Angele, CA 90025 -7121 |
| Contact | Jay Geller |
| Correspondent | Jay Geller THE BINDING SITE GROUP, LTD. Los Angele, CA 90025 -7121 |
| Product Code | CZW |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-21 |
| Decision Date | 2010-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017596 | K100179 | 000 |
| 05051700015578 | K100179 | 000 |