The following data is part of a premarket notification filed by Intl. Remote Imaging Systems with the FDA for 939udx Urine Pathology System.
Device ID | K000373 |
510k Number | K000373 |
Device Name: | 939UDX URINE PATHOLOGY SYSTEM |
Classification | Counter, Urine Particle |
Applicant | INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
Contact | Harvey L Kasdan |
Correspondent | Harvey L Kasdan INTL. REMOTE IMAGING SYSTEMS 9162 ETON AVE. Chatsworth, CA 91311 |
Product Code | LKM |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-04 |
Decision Date | 2000-04-14 |