510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862083Substantially Equivalent

Hygeia Sciences Urine Hcg Flow Thorugh Assay

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

K862083 is the FDA 510(k) clearance record for HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY, a class II device, cleared for Hygeia Sciences on under FDA product code JHJ (Agglutination Method, Human Chorionic Gonadotropin). FDA records list 4 510(k) clearances for Hygeia Sciences, from to . As of , FDA records show no recalls naming K862083.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JHJ Agglutination Method, Human Chorionic Gonadotropin
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hygeia Sciences 330 Nevada St., Newton MA
Third party review
No

Clearances, product code JHJ

Trailing 12 months

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

FDA records show no clearances under product code JHJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JHJ, 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