
Sigma Chemical Co.
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MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES is an FDA 510(k)-cleared medical device (K845014) manufactured by Sigma Chemical Co.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 26, 1985. Regulation: 8.