K884207 is an FDA 510(k) clearance for the RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 2, 1988, 57 days after receiving the submission on October 6, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K884207 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 1988 |
| Decision Date | December 02, 1988 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |