Olympus Ck-Mb Reagent

FDA 510(k) K971817 · Olympus America, Inc.

Substantially Equivalent

510(k) numberK971817

Submission

Device name
Olympus Ck-Mb Reagent
Applicant
Olympus America, Inc.
Melville, NY, US
Received
May 16, 1997
Decision date
June 11, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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

Other 510(k)s with product code JLB

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K992140Piccolo Metlyte 7 Reagent DiscJLB · Traditional Abaxis, Inc.08/26/1999SE
K782156Unitest Creatine KinaseJLB · Traditional Boehringer Mannheim Corp.03/02/1979SE

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Questions and answers

When was Olympus Ck-Mb Reagent cleared by the FDA?

Olympus Ck-Mb Reagent (K971817) received a 510(k) decision of Substantially Equivalent on June 11, 1997, 26 days after the submission was received.

What is the product code of K971817?

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