
Astoria-Pacific, Inc.
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ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K is an FDA 510(k)-cleared medical device (K010844) manufactured by Astoria-Pacific, Inc.. 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 September 20, 2001. Regulation: 8.