ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is an FDA 510(k)-cleared medical device (K973743) manufactured by Beckman Instruments, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 30, 1997. Regulation: 8.