The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Staphytect-od.
Device ID | K940557 |
510k Number | K940557 |
Device Name: | STAPHYTECT-OD |
Classification | Staphylococcus Aureus Protein A Insoluble |
Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
Contact | Louise Roberts |
Correspondent | Louise Roberts UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
Product Code | LHJ |
CFR Regulation Number | 866.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-07 |
Decision Date | 1994-07-28 |