The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Serodot Cmv (cytomegalovirus) Igg Test Kit.
| Device ID | K875361 |
| 510k Number | K875361 |
| Device Name: | SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Contact | El-badry |
| Correspondent | El-badry DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-05-13 |