The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Modified Ddi Serocard Herpes Igg Test Kit.
| Device ID | K884246 |
| 510k Number | K884246 |
| Device Name: | MODIFIED DDI SEROCARD HERPES IGG TEST KIT |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Contact | El-badry, Phd |
| Correspondent | El-badry, Phd DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1989-04-10 |