The following data is part of a premarket notification filed by Tosoh Corp. with the FDA for St Aia-pack Ca 19-9.
| Device ID | K023240 |
| 510k Number | K023240 |
| Device Name: | ST AIA-PACK CA 19-9 |
| Classification | System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer |
| Applicant | TOSOH CORP. 73 COGWHEEL LN. Seymour, CT 06483 |
| Contact | Judith E Loebel |
| Correspondent | Judith E Loebel TOSOH CORP. 73 COGWHEEL LN. Seymour, CT 06483 |
| Product Code | NIG |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-12-23 |