Lig/Tdm a, B, C

FDA 510(k) K901212 · Ciba Corning Diagnostics Corp.

Substantially Equivalent

510(k) numberK901212

Submission

Device name
Lig/Tdm a, B, C
Applicant
Ciba Corning Diagnostics Corp.
East Walpole, MA, US
Received
March 14, 1990
Decision date
May 1, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJY – Multi-Analyte Controls, All Kinds (Assayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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Questions and answers

When was Lig/Tdm a, B, C cleared by the FDA?

Lig/Tdm a, B, C (K901212) received a 510(k) decision of Substantially Equivalent on May 1, 1990, 48 days after the submission was received.

What is the product code of K901212?

The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.