The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Influenza A Ifa Test For Direct Antigen Detection.
| Device ID | K884191 |
| 510k Number | K884191 |
| Device Name: | INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Howard Taylor |
| Correspondent | Howard Taylor BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-11-22 |