K940817 is an FDA 510(k) clearance for the TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II. This device is classified as a Colorimetric Method, Lecithin/sphingomyelin Ratio (Class II - Special Controls, product code JHF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 8, 1995, 351 days after receiving the submission on February 22, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1455.
| 510(k) Number | K940817 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 22, 1994 |
| Decision Date | February 08, 1995 |
| Days to Decision | 351 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JHF — Colorimetric Method, Lecithin/sphingomyelin Ratio |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1455 |