The following data is part of a premarket notification filed by Inverness Medical-biostar Inc. with the FDA for Biostar Oia Shigatox.
| Device ID | K061889 |
| 510k Number | K061889 |
| Device Name: | BIOSTAR OIA SHIGATOX |
| Classification | Antigens, All Types, Escherichia Coli |
| Applicant | INVERNESS MEDICAL-BIOSTAR INC. 331 SOUTH 104TH ST. Louisville, CO 80516 |
| Contact | Robin C Hart |
| Correspondent | Robin C Hart INVERNESS MEDICAL-BIOSTAR INC. 331 SOUTH 104TH ST. Louisville, CO 80516 |
| Product Code | GMZ |
| CFR Regulation Number | 866.3255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-12-12 |
| Summary: | summary |