The following data is part of a premarket notification filed by Casco Standards with the FDA for Tdm I Linearity Test Set.
| Device ID | K913309 |
| 510k Number | K913309 |
| Device Name: | TDM I LINEARITY TEST SET |
| Classification | Drug Mixture Control Materials |
| Applicant | CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Contact | Glenn George |
| Correspondent | Glenn George 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 | 1991-07-25 |
| Decision Date | 1991-09-13 |