510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K103548Substantially Equivalent

Advia Centaur Calibarator 80 Model 10492491

Siemens Healthcare Diagnostics Inc., East Walpole MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103548 is the FDA 510(k) clearance record for ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491, a class II device, cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code JIT (Calibrator, Secondary). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show no recalls naming K103548.

Clearance record

Decision date
Received
(181 days to decision)
Product code
JIT Calibrator, Secondary
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Siemens Healthcare Diagnostics, Inc. 333 Coney St., East Walpole MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIT

Trailing 12 months

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

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