The following data is part of a premarket notification filed by Scimedx Tekfile Services with the FDA for Serodia Tp-pa.
| Device ID | K971502 |
| 510k Number | K971502 |
| Device Name: | SERODIA TP-PA |
| Classification | Antigens, Ha, Treponema Pallidum |
| Applicant | SCIMEDX TEKFILE SERVICES 400 FORD RD. Denvill, NJ 07834 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus SCIMEDX TEKFILE SERVICES 400 FORD RD. Denvill, NJ 07834 |
| Product Code | GMT |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-24 |
| Decision Date | 1997-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850212007027 | K971502 | 000 |
| 00850212007010 | K971502 | 000 |
| 00869164000062 | K971502 | 000 |
| 00869164000055 | K971502 | 000 |