The following data is part of a premarket notification filed by Casco Standards with the FDA for Document(r) Ammonia/ethanol Aqueous Control.
| Device ID | K945315 |
| 510k Number | K945315 |
| Device Name: | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CASCO STANDARDS 500 RIVERSIDE INDUSTRIAL PARK Portland, ME 04103 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1994-12-09 |