The following data is part of a premarket notification filed by Iverness Medical Professional Diagnostics with the FDA for Modification To Biostar Oia Shigatox.
| Device ID | K071799 |
| 510k Number | K071799 |
| Device Name: | MODIFICATION TO BIOSTAR OIA SHIGATOX |
| Classification | Antisera, All Types, Escherichia Coli |
| Applicant | IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. Louisville, CO 80027 |
| Contact | Robin C Hart |
| Correspondent | Robin C Hart IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS 331 SOUTH 104TH ST. Louisville, CO 80027 |
| Product Code | GNA |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-10-02 |
| Summary: | summary |