The following data is part of a premarket notification filed by General Diagnostics with the FDA for Profile Cardiac Set Assayed Serum Contr..
| Device ID | K803036 |
| 510k Number | K803036 |
| Device Name: | PROFILE CARDIAC SET ASSAYED SERUM CONTR. |
| Classification | Drug Mixture Control Materials |
| Applicant | GENERAL DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-01 |
| Decision Date | 1980-12-22 |