The following data is part of a premarket notification filed by Bionime Corporation with the FDA for Rightest Control Solution.
| Device ID | K133003 |
| 510k Number | K133003 |
| Device Name: | RIGHTEST CONTROL SOLUTION |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BIONIME CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Contact | Jigar Shah |
| Correspondent | Jigar Shah BIONIME CORPORATION 55 NORTHERN BLVD. SUITE 200 Great Neck, NY 11021 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2013-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883489001603 | K133003 | 000 |
| 00883489001047 | K133003 | 000 |