510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160202Substantially Equivalent

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

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

K160202 is the FDA 510(k) clearance record for Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL), a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code LEH (Radioimmunoassay, Vancomycin). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show no recalls naming K160202.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LEH Radioimmunoassay, Vancomycin
Regulation
21 CFR 862.3950
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr., P.O. Box 6101 Ms 514, Newark DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LEH

Trailing 12 months

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

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