The following data is part of a premarket notification filed by General Biometrics, Inc. with the FDA for Immunodot Infectious Mononucleosis Test.
| Device ID | K894975 |
| 510k Number | K894975 |
| Device Name: | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Contact | Kiehl, Phd |
| Correspondent | Kiehl, Phd GENERAL BIOMETRICS, INC. 15222 Avenue Of Science Suite A San Diego, CA 92128 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1989-09-13 |