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510(k) Data Aggregation
K Number
K081896Device Name
BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH
Manufacturer
Date Cleared
2008-08-20
(48 days)
Regulation Number
884.6160Why did this record match?
Applicant Name (Manufacturer) :
BIOGENICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The plate is a sterile non-pyrogenic, Embryotoxicity tested single use plasticware intended for preparing, storing, manipulating or transferring human gametes or incended for proparing, (IVF), or other in vitro fertilization techniques or cell culture.
Device Description
Biogenics BioQuad™ 4-Well IVF Culture Dish
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