Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Wako Chemicals USA, Inc.
Free shipping on orders over $99 · 30-day returns
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 is an FDA 510(k)-cleared medical device (K080123) manufactured by Wako Chemicals USA, 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 July 16, 2008. Regulation: 8.