The following data is part of a premarket notification filed by Casco Standards with the FDA for Document Tdm Ultra Unassayed Control.
| Device ID | K955155 |
| 510k Number | K955155 |
| Device Name: | DOCUMENT TDM ULTRA UNASSAYED CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Contact | Christine V Beach |
| Correspondent | Christine V Beach CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-13 |
| Decision Date | 1995-12-20 |