The following data is part of a premarket notification filed by The Binding Site with the FDA for Spaplus Analyzer.
| Device ID | K100455 |
| 510k Number | K100455 |
| Device Name: | SPAPLUS ANALYZER |
| Classification | Complement C4, 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 | DBI |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700017602 | K100455 | 000 |
| 05051700015585 | K100455 | 000 |