K880821 is an FDA 510(k) clearance for the RESUBMITTED ABBOTT TESTPACK ROTAVIRUS. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I - General Controls, product code LIQ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1988, 66 days after receiving the submission on March 1, 1988.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3405.
| 510(k) Number | K880821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1988 |
| Decision Date | May 06, 1988 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3405 |