The following data is part of a premarket notification filed by Casco Standards with the FDA for Document Ammonia/ethanol/lactate Calibrator, Pn: M-109.
| Device ID | K981436 |
| 510k Number | K981436 |
| Device Name: | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | CASCO STANDARDS 500 RIVERSIDE INDUSTRIAL PARK Portland, ME 04103 |
| Contact | Christine V Beach |
| Correspondent | Christine V Beach CASCO STANDARDS 500 RIVERSIDE INDUSTRIAL PARK Portland, ME 04103 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-14 |
| Decision Date | 1998-04-24 |