510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864824Substantially Equivalent

Infectious Tissue Kit

American Scientific Products, Waukegan IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864824 is the FDA 510(k) clearance record for INFECTIOUS TISSUE KIT, cleared for American Scientific Products on . FDA records list 28 510(k) clearances for American Scientific Products, from to . As of , FDA records show no recalls naming K864824.

Clearance record

Decision date
Received
(15 days to decision)
Review panel
Unknown
Applicant
American Scientific Products 1430 Waukegan Rd., Waukegan IL
Third party review
No