510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863636Substantially Equivalent

Updated Sterile General Hospital Instruments

Biological & Environmental Control Laboratories, Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863636 is the FDA 510(k) clearance record for UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS, cleared for Biological & Environmental Control Laboratories on . FDA records list 20 510(k) clearances for Biological & Environmental Control Laboratories, from to . As of , FDA records show no recalls naming K863636.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Biological & Environmental Control Laboratories 615 Front St., Toledo OH
Third party review
No