510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K081683Substantially Equivalent

Loci Cardiac Troponin I Calibrator, Model Rc621

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

K081683 is the FDA 510(k) clearance record for LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621, a class II device, cleared for Siemens Healthcare Diagnostics on under FDA product code JIT (Calibrator, Secondary). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, from to . As of , FDA records show 3 recalls naming K081683.

Clearance record

Decision date
Received
(20 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 Ms 514, P.O. Box 6101, Newark DE
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIT, 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