
Boehringer Mannheim Corp.
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REFLOTRON CREATININE TEST TABS is an FDA 510(k)-cleared medical device (K913105) manufactured by Boehringer Mannheim Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1991. Regulation: 8.