The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia-pack Intact Pth Assay.
| Device ID | K063605 |
| 510k Number | K063605 |
| Device Name: | ST AIA-PACK INTACT PTH ASSAY |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | Tosoh BioScience, Inc. 3600 GANTZ ROAD Grove City, OH 43123 |
| Contact | Charles P Gill |
| Correspondent | Charles P Gill Tosoh BioScience, Inc. 3600 GANTZ ROAD Grove City, OH 43123 |
| Product Code | CEW |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-04 |
| Decision Date | 2007-06-21 |
| Summary: | summary |