510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864360Substantially Equivalent

Ldh-P (Lactic Dehydrogenase) Reagent - Sce

Trace Scientific, Ltd., Clayton, Vic 3168, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864360 is the FDA 510(k) clearance record for LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE, cleared for Trace Scientific , Ltd. on . FDA records list 55 510(k) clearances for Trace Scientific , Ltd., from to . As of , FDA records show no recalls naming K864360.

Clearance record

Decision date
Received
(95 days to decision)
Review panel
Unknown
Applicant
Trace Scientific , Ltd. 10 Treforest Dr., Clayton, Vic 3168, AU
Third party review
No