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Alfa Scientific Designs, Inc.
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MODIFICATION TO INSTANT-VIEW METHAMPHETYAMINE (METH1000) URINE TEST (CASSETTE) is an FDA 510(k)-cleared medical device (K003847) manufactured by Alfa Scientific Designs, Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2001. Regulation: 8.