The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Medica Easyqc Blood Gas/electrolyte Control.
| Device ID | K021930 |
| 510k Number | K021930 |
| Device Name: | MEDICA EASYQC BLOOD GAS/ELECTROLYTE CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01432 |
| Contact | Kathy Storro |
| Correspondent | Kathy Storro BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01432 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-12 |
| Decision Date | 2002-06-25 |
| Summary: | summary |