Device Atlas

GC Oia

Q: When was GC Oia cleared by the FDA?

GC Oia (K023947) received a 510(k) decision of Substantially Equivalent on April 17, 2003, 141 days after the submission was received.

Q: What is the product code of K023947?

The FDA product code is LIR – Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae, a Class II (moderate risk) device regulated under 21 CFR 866.3390.

FDA 510(k) K023947 · Thermo Biostar, Inc.

Substantially Equivalent

510(k) numberK023947

Submission

Device name: GC Oia
Applicant: Thermo Biostar, Inc.
Louisville, CO, US
Received: November 27, 2002
Decision date: April 17, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LIR – Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3390
Specialty: Microbiology

Other 510(k)s with product code LIR

510(k)	Device	Applicant	Decision
K882534	Abbott Testpack(Tm) Gonorrhea Positive ControlLIR · Traditional	Abbott Laboratories	07/12/1988SE
K881064	Hygeia GC TestLIR · Traditional	Hygeia Sciences	06/02/1988SE

More from Hygeia Sciences

510(k)	Device	Decision
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K023556	Flu Oia A/B Test KitPSZ · Traditional	03/27/2003SE
K023779	RSV OiaGQG · Traditional	01/14/2003SE
K021172	RSV OiaGOG · Traditional	09/13/2002SE

Questions and answers

When was GC Oia cleared by the FDA?

GC Oia (K023947) received a 510(k) decision of Substantially Equivalent on April 17, 2003, 141 days after the submission was received.

What is the product code of K023947?

The FDA product code is LIR – Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae, a Class II (moderate risk) device regulated under 21 CFR 866.3390.