The following data is part of a premarket notification filed by Immunostics, Inc. with the FDA for Rubellacol.
| Device ID | K031490 |
| 510k Number | K031490 |
| Device Name: | RUBELLACOL |
| Classification | Latex Agglutination Assay, Rubella |
| Applicant | IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Contact | Jeffrey Fleishman |
| Correspondent | Jeffrey Fleishman IMMUNOSTICS, INC. 3505 SUNSET AVE. Ocean, NJ 07712 |
| Product Code | LQN |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-12 |
| Decision Date | 2003-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057021635 | K031490 | 000 |
| 20885380020190 | K031490 | 000 |
| 20885380020206 | K031490 | 000 |
| 00816057020409 | K031490 | 000 |
| 00816057020416 | K031490 | 000 |
| 00816057020423 | K031490 | 000 |
| 00816057020430 | K031490 | 000 |
| 00816057020447 | K031490 | 000 |
| 00816057020454 | K031490 | 000 |
| 20885380020183 | K031490 | 000 |