Piccolo Metlyte 7 Reagent Disc

FDA 510(k) K992140 · Abaxis, Inc.

Substantially Equivalent

510(k) numberK992140

Submission

Device name
Piccolo Metlyte 7 Reagent Disc
Applicant
Abaxis, Inc.
Sunnyvale, CA, US
Received
June 24, 1999
Decision date
August 26, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

510(k)DeviceApplicantDecision
K971817Olympus Ck-Mb ReagentJLB · Traditional Olympus America, Inc.06/11/1997SE
K782156Unitest Creatine KinaseJLB · Traditional Boehringer Mannheim Corp.03/02/1979SE

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Questions and answers

When was Piccolo Metlyte 7 Reagent Disc cleared by the FDA?

Piccolo Metlyte 7 Reagent Disc (K992140) received a 510(k) decision of Substantially Equivalent on August 26, 1999, 63 days after the submission was received.

What is the product code of K992140?

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