510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935049Substantially Equivalent

Elegance Neonatal Tsh Elisa

Bioclone Australia Pty, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935049 is the FDA 510(k) clearance record for ELEGANCE NEONATAL TSH ELISA, a class II device, cleared for Bioclone Australia Pty , Ltd. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 10 510(k) clearances for Bioclone Australia Pty , Ltd., from to . As of , FDA records show no recalls naming K935049.

Clearance record

Decision date
Received
(348 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bioclone Australia Pty , Ltd. 1920 N St., NW Suite 650, Washington DC
510(k) summary
Summary
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