The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Cmv Igg Antibody Test (indirect Fluorescent Test).
| Device ID | K893468 |
| 510k Number | K893468 |
| Device Name: | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) |
| Classification | Antisera, Conjugated Fluorescent, Cytomegalovirus |
| Applicant | IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Contact | Don W Valencia |
| Correspondent | Don W Valencia IMMUNO CONCEPTS, INC. 9779-D BUSINESS PARK DR. Sacramento, CA 95827 |
| Product Code | LIN |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-03 |
| Decision Date | 1989-07-14 |