510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881064Substantially Equivalent

Hygeia Gc Test

Hygeia Sciences, Newton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881064 is the FDA 510(k) clearance record for HYGEIA GC TEST, a class II device, cleared for Hygeia Sciences on under FDA product code LIR (Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae). FDA records list 4 510(k) clearances for Hygeia Sciences, from to . As of , FDA records show no recalls naming K881064.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LIR Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Regulation
21 CFR 866.3390
Device class
Class II
Review panel
Microbiology
Applicant
Hygeia Sciences 330 Nevada St., Newton MA
Third party review
No

Clearances, product code LIR

Trailing 12 months

FDA records hold no clearances under product code LIR in the trailing twelve months.

FDA records show no clearances under product code LIR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260