K874127 is an FDA 510(k) clearance for the ABBOTT TESTPACK RSV. This device is classified as a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I - General Controls, product code GQG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1988, 206 days after receiving the submission on October 13, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K874127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1987 |
| Decision Date | May 06, 1988 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |