K870089 is an FDA 510(k) clearance for the IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT. This device is classified as a Antisera, All Groups, N. Meningitidis (Class II - Special Controls, product code GTJ).
Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on March 17, 1987, 67 days after receiving the submission on January 9, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K870089 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1987 |
| Decision Date | March 17, 1987 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTJ — Antisera, All Groups, N. Meningitidis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |