The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Turbox.
Device ID | K873401 |
510k Number | K873401 |
Device Name: | TURBOX |
Classification | Nephelometer |
Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
Contact | George Zajicek |
Correspondent | George Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
Product Code | JZW |
CFR Regulation Number | 866.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-24 |
Decision Date | 1987-09-23 |