510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K781143Substantially Equivalent

Immunofluorescence Test Kit

Microbiological Assoc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781143 is the FDA 510(k) clearance record for IMMUNOFLUORESCENCE TEST KIT, cleared for Microbiological Assoc. on . FDA records list 8 510(k) clearances for Microbiological Assoc., from to . As of , FDA records show no recalls naming K781143.

Clearance record

Decision date
Received
(35 days to decision)
Review panel
Unknown
Applicant
Microbiological Assoc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No