Device Atlas

Hygeia GC Test

Q: When was Hygeia GC Test cleared by the FDA?

Hygeia GC Test (K881064) received a 510(k) decision of Substantially Equivalent on June 2, 1988, 80 days after the submission was received.

Q: What is the product code of K881064?

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) K881064 · Hygeia Sciences

Substantially Equivalent

510(k) numberK881064

Submission

Device name: Hygeia GC Test
Applicant: Hygeia Sciences
Newton, MA, US
Received: March 14, 1988
Decision date: June 2, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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
K023947	GC OiaLIR · Traditional	Thermo Biostar, Inc.	04/17/2003SE
K882534	Abbott Testpack(Tm) Gonorrhea Positive ControlLIR · Traditional	Abbott Laboratories	07/12/1988SE

More from Abbott Laboratories

510(k)	Device	Decision
K882192	Hygeia Urine Pregnancy TestDHA · Traditional	11/10/1988SE
K862083	Hygeia Sciences Urine HCG Flow Thorugh AssayJHJ · Traditional	07/02/1986SE
K862133	Hygeia Rapid Strep a TestGTY · Traditional	06/25/1986SE

Questions and answers

When was Hygeia GC Test cleared by the FDA?

Hygeia GC Test (K881064) received a 510(k) decision of Substantially Equivalent on June 2, 1988, 80 days after the submission was received.

What is the product code of K881064?

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.