510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081074Substantially Equivalent

Dimension Tshl Flex Reagent Cartridge and Tsh Sample Diluent with Models RF 612 and Kd691

Siemens Healthcare Diagnostics Inc., Newark DE / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081074 is the FDA 510(k) clearance record for DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show 3 recalls naming K081074.

Clearance record

Decision date
Received
(37 days to decision)
Product code
JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Regulation
21 CFR 862.1690
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark DE
510(k) summary
Summary PDF
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