The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for St Aia-pack Ca 125 Enzyme Immunoassay.
| Device ID | K023891 |
| 510k Number | K023891 |
| Device Name: | ST AIA-PACK CA 125 ENZYME IMMUNOASSAY |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| Applicant | TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Contact | Lois Nakayama |
| Correspondent | Lois Nakayama TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Product Code | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-22 |
| Decision Date | 2002-12-06 |
| Summary: | summary |