The following data is part of a premarket notification filed by Bionostics, Inc. with the FDA for Rna1c Hemoglobin A1c Control For Bayer Dca2000 And Dca2000+ Analyzer.
| Device ID | K050100 |
| 510k Number | K050100 |
| Device Name: | RNA1C HEMOGLOBIN A1C CONTROL FOR BAYER DCA2000 AND DCA2000+ ANALYZER |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-02-25 |
| Summary: | summary |