
Photec Diagnostics, Inc.
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THEOPHYLLINE TEST KIT REF. #A874799 is an FDA 510(k)-cleared medical device (K880291) manufactured by Photec Diagnostics, 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 March 23, 1988. Regulation: 8.