The following data is part of a premarket notification filed by Microscan Div. Baxter Healthcare Corp. with the FDA for Immunoscan(tm) Direct Neisseria Meningitidis Kit.
| Device ID | K870089 |
| 510k Number | K870089 |
| Device Name: | IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT |
| Classification | Antisera, All Groups, N. Meningitidis |
| Applicant | MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Contact | Lorraine Weaver |
| Correspondent | Lorraine Weaver MICROSCAN DIV. BAXTER HEALTHCARE CORP. 2040 ENTERPRISE BLVD. W. Sacramento, CA 95691 |
| Product Code | GTJ |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-09 |
| Decision Date | 1987-03-17 |