The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Multi-meter Glucose Calibration Verification Material, Model Rna Gl3.
Device ID | K012430 |
510k Number | K012430 |
Device Name: | MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
Contact | Kathy Storro |
Correspondent | Kathy Storro BIONOSTICS, INC. 2 CRAIG RD. Acton, MA 01720 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-31 |
Decision Date | 2001-08-27 |
Summary: | summary |