The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, Co2 Acid Reagent A443-330, Co2 Alkaline Buffer A44.
| Device ID | K982501 |
| 510k Number | K982501 |
| Device Name: | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Janet A Mcgrath |
| Correspondent | Janet A Mcgrath ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-20 |
| Decision Date | 1998-09-01 |
| Summary: | summary |