K884193 is an FDA 510(k) clearance for the PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT. This device is classified as a Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 (Class I - General Controls, product code GQS).
Submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 1988, 47 days after receiving the submission on October 6, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3400.
| 510(k) Number | K884193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1988 |
| Decision Date | November 22, 1988 |
| Days to Decision | 47 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 |