Calcium Gen. 2

FDA 510(k) K113521 · Roche Diagnostics

Substantially Equivalent

510(k) numberK113521

Submission

Device name
Calcium Gen. 2
Applicant
Roche Diagnostics
Indianapolis, IN, US
Received
November 29, 2011
Decision date
May 8, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CHW – Titrimetric With Edta And Indicator, Calcium
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1145
Specialty
Clinical Chemistry

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Questions and answers

When was Calcium Gen. 2 cleared by the FDA?

Calcium Gen. 2 (K113521) received a 510(k) decision of Substantially Equivalent on May 8, 2012, 161 days after the submission was received.

What is the product code of K113521?

The FDA product code is CHW – Titrimetric With Edta And Indicator, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.