K871230 is an FDA 510(k) clearance for the ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS. This device is classified as a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I - General Controls, product code LKT).
Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on June 26, 1987, 91 days after receiving the submission on March 27, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K871230 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1987 |
| Decision Date | June 26, 1987 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |