The following data is part of a premarket notification filed by Murex Diagnostics, Inc. with the FDA for Wellcolex E-coli Oi57 Zc60.
| Device ID | K962028 |
| 510k Number | K962028 |
| Device Name: | WELLCOLEX E-COLI OI57 ZC60 |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | MUREX DIAGNOSTICS, INC. 3705 NORTHWOODS CIRCLE Norcross, GA 30071 |
| Contact | Ken Shockley, Ph.d. |
| Correspondent | Ken Shockley, Ph.d. MUREX DIAGNOSTICS, INC. 3705 NORTHWOODS CIRCLE Norcross, GA 30071 |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-23 |
| Decision Date | 1996-11-01 |