The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Fdi Glucose Control Solution For Use With Accu-chek Aviva.
Device ID | K123612 |
510k Number | K123612 |
Device Name: | FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | FUJIREBIO DIAGNOSTICS, INC. 940 CROSSROADS BLVD. Seguin, TX 78155 |
Contact | Kent Pruett |
Correspondent | Kent Pruett FUJIREBIO DIAGNOSTICS, INC. 940 CROSSROADS BLVD. Seguin, TX 78155 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-23 |
Decision Date | 2013-01-17 |
Summary: | summary |