Submission Details
| 510(k) Number | K071799 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 2007 |
| Decision Date | October 02, 2007 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
MODIFICATION TO BIOSTAR OIA SHIGATOX
Oct 2007
Decision
92d
Days
Class 1
Risk
About This 510(k) Submission
K071799 is an FDA 510(k) clearance for the MODIFICATION TO BIOSTAR OIA SHIGATOX, a Antisera, All Types, Escherichia Coli (Class I — General Controls, product code GNA), submitted by Iverness Medical Professional Diagnostics (Louisville, US). The FDA issued a Cleared decision on October 2, 2007, 92 days after receiving the submission on July 2, 2007. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.
Device Classification
| Product Code | GNA — Antisera, All Types, Escherichia Coli |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3255 |
Manufacturer
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