K930640 is an FDA 510(k) clearance for the PRECISE PREGNANCY. This device is classified as a Kit, Test, Pregnancy, Hcg, Over The Counter (Class II - Special Controls, product code LCX).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on March 18, 1993, 49 days after receiving the submission on January 28, 1993.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K930640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1993 |
| Decision Date | March 18, 1993 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LCX — Kit, Test, Pregnancy, Hcg, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |