Unitest Creatine Kinase

FDA 510(k) K782156 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK782156

Submission

Device name
Unitest Creatine Kinase
Applicant
Boehringer Mannheim Corp.
Walker, MI, US
Received
December 22, 1978
Decision date
March 2, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JLB – Atp And Creatine Kinase (Enzymatic), Creatine
Device class
Class I (low risk)
Regulation
21 CFR 862.1210
Specialty
Clinical Chemistry

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Questions and answers

When was Unitest Creatine Kinase cleared by the FDA?

Unitest Creatine Kinase (K782156) received a 510(k) decision of Substantially Equivalent on March 2, 1979, 70 days after the submission was received.

What is the product code of K782156?

The FDA product code is JLB – Atp And Creatine Kinase (Enzymatic), Creatine, a Class I (low risk) device regulated under 21 CFR 862.1210.