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510(k) K201049

Device
FINDER G6PD
Applicant
Baebies, Inc.
510(k) number
K201049
Product code
JBF  
Decision
Substantially Equivalent (SESE)
Decision date
2022-09-14
Date received
2020-04-21
Regulation
864.7360
Classification name
Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ailen Gillette
Address
615 Davis Dr., Suite 800 Morrisville NC US 27560 27560

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JBF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161364BinaxNOW G6PD TestAlere Scarborough, Inc.2016-06-17
K080003BINAXNOW G6PD TESTBinax, Inc.2008-10-23
K024006G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASEPointe Scientific, Inc.,2003-03-31
K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-ASigma Diagnostics, Inc.1995-06-29

Legacy Summary#

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FDA Review#

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