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510(k) Data Aggregation
(17 days)
LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.
Liquichek Homocysteine Control is prepared from human serum with added Liquichek Homocystellie Control is propared from hands been is provided in liquid form for convenience. This product contains
The provided text lacks information regarding acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (Liquichek Homocysteine Control), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance acceptance criteria and study results.
Therefore, I cannot provide the requested information.
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