510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913963Substantially Equivalent

Immuchem Neonatal Tsh-Mp Elisa

Icn Biomedicals, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913963 is the FDA 510(k) clearance record for IMMUCHEM NEONATAL TSH-MP ELISA, a class II device, cleared for Icn Biomedicals, Inc. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 11 510(k) clearances for Icn Biomedicals, Inc., from to . As of , FDA records show no recalls naming K913963.

Clearance record

Decision date
Received
(99 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Icn Biomedicals, Inc. 3300 Hyland Ave., Costa Mesa CA
510(k) summary
Statement
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