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 |