510(k) K023947

Device: GC OIA
Applicant: THERMO BIOSTAR, INC.
510(k) number: K023947
Product code: LIR
Decision: Substantially Equivalent (SESE)
Decision date: 2003-04-17
Date received: 2002-11-27
Regulation: 866.3390
Classification name: Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JOHN G ADAMS
Address: 331 S. 104th St. Louisville CO US 80027 80027

Source Documents#

Other 510(k) Records For Product Code LIR #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K882534	ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL	Abbott Laboratories	1988-07-12
K881064	HYGEIA GC TEST	Hygeia Sciences	1988-06-02

Legacy Summary#

summary

FDA Review#

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