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 |