510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K982880Substantially Equivalent

Dimension(r) Valproic (Valp) Acid Method

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

K982880 is the FDA 510(k) clearance record for DIMENSION(R) VALPROIC (VALP) ACID METHOD, a class II device, cleared for Dade Behring, Inc. on under FDA product code LEG (Enzyme Immunoassay, Valproic Acid). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K982880.

Clearance record

Decision date
Received
(11 days to decision)
Product code
LEG Enzyme Immunoassay, Valproic Acid
Regulation
21 CFR 862.3645
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Dade Behring, Inc. Bldg. 500 Mail Box 514, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code LEG

Trailing 12 months

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

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