Product code LIR

Device name: Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Medical specialty: Microbiology
Device class: 2
Regulation number: 866.3390
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K023947	GC OIA	Thermo Biostar, Inc.	2003-04-17
K882534	ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL	Abbott Laboratories	1988-07-12
K881064	HYGEIA GC TEST	Hygeia Sciences	1988-06-02

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