The following data is part of a premarket notification filed by Casco Standards with the FDA for Document R Ammonia / Ethanol Calibration Verification Rest Set.
| Device ID | K944338 |
| 510k Number | K944338 |
| Device Name: | DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CASCO STANDARDS P.O BOX 970 Yarmouth, ME 04096 |
| Contact | Lenity J Larrabee |
| Correspondent | Lenity J Larrabee CASCO STANDARDS P.O BOX 970 Yarmouth, ME 04096 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-06 |
| Decision Date | 1994-11-15 |