HBA1C Linearity Set

FDA 510(k) K052010 · Cone Bioproducts

Substantially Equivalent

510(k) numberK052010

Submission

Device name
HBA1C Linearity Set
Applicant
Cone Bioproducts
Seguin, TX, US
Received
July 25, 2005
Decision date
October 4, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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Questions and answers

When was HBA1C Linearity Set cleared by the FDA?

HBA1C Linearity Set (K052010) received a 510(k) decision of Substantially Equivalent on October 4, 2005, 71 days after the submission was received.

What is the product code of K052010?

The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.