K896270 is an FDA 510(k) clearance for the AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081. This device is classified as a Radioimmunoassay, Estradiol (Class I - General Controls, product code CHP).
Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on December 12, 1989, 42 days after receiving the submission on October 31, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1260.
| 510(k) Number | K896270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1989 |
| Decision Date | December 12, 1989 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHP — Radioimmunoassay, Estradiol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1260 |