510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852675Substantially Equivalent

Amerlex-M B-Human Chorionic Gonadtropin Radioi Kit

Amersham Corp., Arlington Heights IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852675 is the FDA 510(k) clearance record for AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT, a class II device, cleared for Amersham Corp. on under FDA product code JHI (Visual, Pregnancy Hcg, Prescription Use). FDA records list 94 510(k) clearances for Amersham Corp., from to . As of , FDA records show no recalls naming K852675.

Clearance record

Decision date
Received
(28 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
Amersham Corp. 2636 S. Clearbrook Dr., Arlington Heights IL
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