The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for Aia-pack Rbc Folate.
| Device ID | K091332 |
| 510k Number | K091332 |
| Device Name: | AIA-PACK RBC FOLATE |
| Classification | Acid, Folic, Radioimmunoassay |
| 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 | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-06 |
| Decision Date | 2009-10-02 |
| Summary: | summary |