510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K981512Substantially Equivalent

Icon Fxhcg Urine/serum Test, Icon Fxhcg Urine Test, Models 40025,40050, 40005 & 41025

Skd, Inc. A Beckman Coulter Co., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981512 is the FDA 510(k) clearance record for ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025, a class II device, cleared for Skd, Inc. A Beckman Coulter Co. on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list one 510(k) clearance for Skd, Inc. A Beckman Coulter Co. As of , FDA records show no recalls naming K981512.

Clearance record

Decision date
Received
(30 days to decision)
Product code
JHI Visual, Pregnancy Hcg, Prescription Use
Regulation
21 CFR 862.1155
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Skd, Inc. A Beckman Coulter Co. 1050 Page Mill Rd.,Bldg. 2b, Palo Alto CA
510(k) summary
Summary
Third party review
No

Clearances, product code JHI

Trailing 12 months
1 clearance under product code JHI in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JHI, 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 20261
October 20260