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Company · CA

Genepoc, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2019. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
NJR	Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test	1
OOI	Real Time Nucleic Acid Amplification System	1
OZN	C. Difficile Toxin Gene Amplification Assay	1
PGX	Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	1
PMY	System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 10, 2019	K190275	GenePOC Carba Genepoc, Inc., CA	PMY
Mar 6, 2019	K183366	GenePOC Strep A Genepoc, Inc., CA	PGX
Nov 22, 2017	K172569	GenePOC CDiff Genepoc, Inc., CA	OZN
May 25, 2017	K170558	revogene Genepoc, Inc., CA	OOI
May 25, 2017	K170557	GenePOC GBS LB Genepoc, Inc., CA	NJR

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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