The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for Aia-pack C-peptide Control Set.
| Device ID | K143296 |
| 510k Number | K143296 |
| Device Name: | AIA-PACK C-Peptide Control Set |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Tosoh BioScience, Inc. 6000 Shoreline Court, Ste. 101 South San Francisco, CA 94080 |
| Contact | Robert L Wick |
| Correspondent | Robert L Wick Tosoh BioScience, Inc. 6000 Shoreline Court, Ste. 101 South San Francisco, CA 94080 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2014-12-16 |