The following data is part of a premarket notification filed by Sangstat Medical Corp. with the FDA for Thymostat Elisa For The Detection Of Human Igg,m And A Anti-rabbit Igg Antibodies.
| Device ID | K973203 |
| 510k Number | K973203 |
| Device Name: | THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | SANGSTAT MEDICAL CORP. 1505 ADAMS DR. Menlo Park, CA 94025 |
| Contact | Hana Berger Moran |
| Correspondent | Hana Berger Moran SANGSTAT MEDICAL CORP. 1505 ADAMS DR. Menlo Park, CA 94025 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-26 |
| Decision Date | 1998-09-30 |