The following data is part of a premarket notification filed by Microscan Div. Baxter Healthcare Corp. with the FDA for Antibody Assay For Detection Of Influenza B.
| Device ID | K871231 |
| 510k Number | K871231 |
| Device Name: | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B |
| Classification | Antigens, Cf (including Cf Control), Influenza Virus A, B, C |
| Applicant | MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Contact | Howard G Taylor |
| Correspondent | Howard G Taylor MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Product Code | GNX |
| CFR Regulation Number | 866.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-27 |
| Decision Date | 1987-06-26 |