The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Modification Of Serocard Rubella Igg Test.
| Device ID | K902571 |
| 510k Number | K902571 |
| Device Name: | MODIFICATION OF SEROCARD RUBELLA IGG TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine, CA 92718 |
| Contact | Julie Whiteside |
| Correspondent | Julie Whiteside DISEASE DETECTION INTERNATIONAL, INC. 2 THOMAS Irvine, CA 92718 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-07 |
| Decision Date | 1990-09-05 |