PARA-PAK MACRO-CON

Device, Parasite Concentration

MERIDIAN DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Para-pak Macro-con.

Pre-market Notification Details

Device IDK860034
510k NumberK860034
Device Name:PARA-PAK MACRO-CON
ClassificationDevice, Parasite Concentration
Applicant MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
ContactMichele M Nickol
CorrespondentMichele M Nickol
MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati,  OH  45244
Product CodeLKS  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-06
Decision Date1986-02-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733102028 K860034 000

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