The following data is part of a premarket notification filed by Oxoid, Ltd. with the FDA for Dryspot E.coli 0157 Kit.
Device ID | K993401 |
510k Number | K993401 |
Device Name: | DRYSPOT E.COLI 0157 KIT |
Classification | Antisera, All Types, Escherichia Coli |
Applicant | OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
Contact | Amanda Sheppard |
Correspondent | Amanda Sheppard OXOID, LTD. WADE RD. Basingstoke, Hampshire, GB Rg24 8pw |
Product Code | GNA |
CFR Regulation Number | 866.3255 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-08 |
Decision Date | 2000-02-28 |