
Sigma Chemical Co.
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MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON is an FDA 510(k)-cleared medical device (K852568) 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 July 11, 1985. Regulation: 8.