510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062319Substantially Equivalent

Calibrator for Automated Systems (C.f.a.s.), Model 10759350 360

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062319 is the FDA 510(k) clearance record for CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360, a class II device, cleared for Roche Diagnostics Corp. on under FDA product code JIX (Calibrator, Multi-Analyte Mixture). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show no recalls naming K062319.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JIX Calibrator, Multi-Analyte Mixture
Regulation
21 CFR 862.1150
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., P.O. Box 50457, Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JIX

Trailing 12 months

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

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