510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842949Substantially Equivalent

Amerlex-M Free T-3 Ria

Amersham Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842949 is the FDA 510(k) clearance record for AMERLEX-M FREE T-3 RIA, a class II device, cleared for Amersham Corp. on under FDA product code CDP (Radioimmunoassay, Total Triiodothyronine). FDA records list 94 510(k) clearances for Amersham Corp., from to . As of , FDA records show no recalls naming K842949.

Clearance record

Decision date
Received
(61 days to decision)
Product code
CDP Radioimmunoassay, Total Triiodothyronine
Regulation
21 CFR 862.1710
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Amersham Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CDP

Trailing 12 months

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

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