K843667 is an FDA 510(k) clearance for the PARAINFLUENZA 3. This device is classified as a Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (Class I - General Controls, product code GQS).
Submitted by Institute Virion , Ltd. (Walker, US). The FDA issued a Cleared decision on September 26, 1985, 374 days after receiving the submission on September 17, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3400.
| 510(k) Number | K843667 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 1984 |
| Decision Date | September 26, 1985 |
| Days to Decision | 374 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQS — Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3400 |