The following data is part of a premarket notification filed by Meridian Bioscience, Inc. with the FDA for Immunocard Stat! E. Coli O157 Plus.
| Device ID | K023599 |
| 510k Number | K023599 |
| Device Name: | IMMUNOCARD STAT! E. COLI O157 PLUS |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Susan Rolih |
| Correspondent | Susan Rolih MERIDIAN BIOSCIENCE, 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 | 2002-10-28 |
| Decision Date | 2003-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840733101816 | K023599 | 000 |