Submission Details
| 510(k) Number | K873564 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 02, 1987 |
| Decision Date | November 20, 1987 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
K873564 - GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES
(FDA 510(k) Clearance)
Nov 1987
Decision
79d
Days
Class 1
Risk
K873564 is an FDA 510(k) clearance for the GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES, a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I — General Controls, product code LKT), submitted by Genetic Systems Corp. (Seattle, US). The FDA issued a Cleared decision on November 20, 1987, 79 days after receiving the submission on September 2, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3480.
Device Classification
| Product Code | LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3480 |
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