The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Roche Combitrol And Autotrol Plus B Multi Analyte Control.
| Device ID | K032453 |
| 510k Number | K032453 |
| Device Name: | ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BIONOSTICS, INC. 7 JACKSON RD. Devens, MA 01432 |
| Contact | Kathleen Storro |
| Correspondent | Kathleen 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 | 2003-08-11 |
| Decision Date | 2003-08-28 |
| Summary: | summary |