K834032 is an FDA 510(k) clearance for the RUBAQUICK DIAGNOSTIC KIT. This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II - Special Controls, product code GOL).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 17, 1984, 147 days after receiving the submission on November 22, 1983.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K834032 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1983 |
| Decision Date | April 17, 1984 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GOL — Antigen, Ha (including Ha Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |