The following data is part of a premarket notification filed by Murex Biotech Ltd. with the FDA for Wellcolex E.coli O157:h7.
| Device ID | K971663 |
| 510k Number | K971663 |
| Device Name: | WELLCOLEX E.COLI O157:H7 |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | MUREX BIOTECH LTD. CENTRAL RD., TEMPLE HILL Dartford,kent, GB Da1 5lr |
| Contact | Rebecca Vine |
| Correspondent | Rebecca Vine MUREX BIOTECH LTD. CENTRAL RD., TEMPLE HILL Dartford,kent, GB Da1 5lr |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-06 |
| Decision Date | 1997-12-30 |