510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K020692Substantially Equivalent

Emit 2000 Vancomycin Assay

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

K020692 is the FDA 510(k) clearance record for EMIT 2000 VANCOMYCIN ASSAY, a class II device, cleared for Dade Behring, 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 K020692.

Clearance record

Decision date
Received
(67 days to decision)
Product code
LEH Radioimmunoassay, Vancomycin
Regulation
21 CFR 862.3950
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Dade Behring, Inc. 514 Gbc Dr., 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LEH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260