510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K850376Substantially Equivalent

Terumo Sensibead Eia Tsh Kit

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850376 is the FDA 510(k) clearance record for TERUMO SENSIBEAD EIA TSH KIT, a class II device, cleared for Terumo Medical Corp. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K850376.

Clearance record

Decision date
Received
(32 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code JLW

Trailing 12 months
1 clearance under product code JLW in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JLW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260