K811588 is an FDA 510(k) clearance for the HELENA FETAL-TEK 200 METHOD. This device is classified as a Chromatographic Separation, Lecithin/sphingomyelin Ratio (Class II - Special Controls, product code JHG).
Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 25, 1981, 17 days after receiving the submission on June 8, 1981.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1455.
| 510(k) Number | K811588 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 1981 |
| Decision Date | June 25, 1981 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JHG — Chromatographic Separation, Lecithin/sphingomyelin Ratio |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1455 |