K882277 is an FDA 510(k) clearance for the ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL. 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 June 22, 1988, 22 days after receiving the submission on May 31, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K882277 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1988 |
| Decision Date | June 22, 1988 |
| Days to Decision | 22 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 |