The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Immunocard Stat! E. Coli O157:h7.
| Device ID | K990263 |
| 510k Number | K990263 |
| Device Name: | IMMUNOCARD STAT! E. COLI O157:H7 |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Allen D Nickol |
| Correspondent | Allen D Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-27 |
| Decision Date | 1999-08-09 |
| Summary: | summary |