The following data is part of a premarket notification filed by Casco Standards with the FDA for Document Ammonia, Ethanol, Lactate Calibrator.
| Device ID | K962629 |
| 510k Number | K962629 |
| Device Name: | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | CASCO STANDARDS P.O BOX 970 Yarmouth, ME 04096 |
| Contact | Christine V Beach |
| Correspondent | Christine V Beach CASCO STANDARDS P.O BOX 970 Yarmouth, ME 04096 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1996-09-13 |
| Summary: | summary |