Cedia Core TDM Multi-Cal

FDA 510(k) K961659 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK961659

Submission

Device name
Cedia Core TDM Multi-Cal
Applicant
Boehringer Mannheim Corp.
Columbus, OH, US
Received
April 30, 1996
Decision date
June 13, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIX – Calibrator, Multi-Analyte Mixture
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

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Questions and answers

When was Cedia Core TDM Multi-Cal cleared by the FDA?

Cedia Core TDM Multi-Cal (K961659) received a 510(k) decision of Substantially Equivalent on June 13, 1996, 44 days after the submission was received.

What is the product code of K961659?

The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.