GENX CULTURE DISH

Labware, Assisted Reproduction

INTL., INC.

The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Genx Culture Dish.

Pre-market Notification Details

Device IDK993881
510k NumberK993881
Device Name:GENX CULTURE DISH
ClassificationLabware, Assisted Reproduction
Applicant INTL., INC. 170 FORT PATH RD. UNIT 14 Madison,  CT  06443
ContactMichael D Cecchi
CorrespondentMichael D Cecchi
INTL., INC. 170 FORT PATH RD. UNIT 14 Madison,  CT  06443
Product CodeMQK  
CFR Regulation Number884.6160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-16
Decision Date2000-02-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815965021812 K993881 000
00815965021805 K993881 000

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