The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Cpr Assay.
| Device ID | K951848 |
| 510k Number | K951848 |
| Device Name: | AIA-PACK CPR ASSAY |
| Classification | Radioimmunoassay, C-peptides Of Proinsulin |
| Applicant | TOSOH MEDICS, INC. 373 D VINTAGE PARK DR. Foster City, CA 94404 |
| Contact | Lori Robinson |
| Correspondent | Lori Robinson TOSOH MEDICS, INC. 373 D VINTAGE PARK DR. Foster City, CA 94404 |
| Product Code | JKD |
| CFR Regulation Number | 862.1135 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-21 |
| Decision Date | 1996-02-13 |