K011684 is an FDA 510(k) clearance for the INFLUENZA A/B RAPID TEST, CAT NO 2158 663. This device is classified as a Devices Detecting Influenza A, B, And C Virus Antigens (Class II - Special Controls, product code PSZ).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 30, 2001, 184 days after receiving the submission on May 30, 2001.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3328. An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection..
| 510(k) Number | K011684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2001 |
| Decision Date | November 30, 2001 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PSZ — Devices Detecting Influenza A, B, And C Virus Antigens |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3328 |
| Definition | An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection. |