510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K013126Substantially Equivalent

N Lp(a) Standard Sy

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

K013126 is the FDA 510(k) clearance record for N LP(A) STANDARD SY, a class II device, cleared for Dade Behring, Inc. on under FDA product code JIS (Calibrator, Primary). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K013126.

Clearance record

Decision date
Received
(51 days to decision)
Product code
JIS Calibrator, Primary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dade Behring, Inc. Glasgow Site, P.O. Box 6101, Newark DE
510(k) summary
Summary
Third party review
No

Clearances, product code JIS

Trailing 12 months

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

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