The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Torch Test Rubella.
| Device ID | K884898 |
| 510k Number | K884898 |
| Device Name: | IMMUNODOT TORCH TEST RUBELLA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | GENERAL BIOMETRICS, INC. 11199 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Contact | Edward F Waddell |
| Correspondent | Edward F Waddell GENERAL BIOMETRICS, INC. 11199 SORRENTO VALLEY RD. San Diego, CA 92121 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-23 |
| Decision Date | 1989-02-03 |