The following data is part of a premarket notification filed by Disease Detection International, Inc. with the FDA for Fluoroslide Pneumocystis Carinii (ifa) Assay.
| Device ID | K884047 |
| 510k Number | K884047 |
| Device Name: | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY |
| Classification | Pneumocystis Carinii |
| Applicant | DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Contact | El-badry, Ph.d. |
| Correspondent | El-badry, Ph.d. DISEASE DETECTION INTERNATIONAL, INC. 17935 SKY PARK CIRCLE, SUITE D Irvine, CA 92714 |
| Product Code | LYF |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-26 |
| Decision Date | 1989-03-14 |