The following data is part of a premarket notification filed by Casco Standards with the FDA for Document Ck Isoenzymes Control.
| Device ID | K915792 |
| 510k Number | K915792 |
| Device Name: | DOCUMENT CK ISOENZYMES CONTROL |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| Applicant | CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Contact | Glennn George |
| Correspondent | Glennn George CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Product Code | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1992-02-06 |