Careside Amylase

FDA 510(k) K990025 · Careside, Inc.

Substantially Equivalent

510(k) numberK990025

Submission

Device name
Careside Amylase
Applicant
Careside, Inc.
Culver City, CA, US
Received
January 4, 1999
Decision date
February 8, 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
JFJ – Catalytic Methods, Amylase
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1070
Specialty
Clinical Chemistry

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More from Sentinel Ch. Srl

510(k)DeviceDecision
K020484Careside LDHCFH · Traditional 07/03/2002SE
K020486Careside GGTJPZ · Traditional 07/01/2002SE
K020487Careside AltCKA · Traditional 06/04/2002SE
K020488Careside TrglycerideCDT · Traditional 04/15/2002SE
K002792Careside CholinesteraseDIH · Traditional 11/08/2000SE
K001462Careside HemoglobinKHG · Traditional 08/21/2000SE
K993771Careside Direct BilirubinCIG · Traditional 12/27/1999SE
K993634Careside AnalyzerJJF · Traditional 12/02/1999SE
K992475Careside CO2, TotalKHS · Traditional 09/15/1999SE
K991717Careside MGJGJ · Traditional 08/10/1999SE

Questions and answers

When was Careside Amylase cleared by the FDA?

Careside Amylase (K990025) received a 510(k) decision of Substantially Equivalent on February 8, 1999, 35 days after the submission was received.

What is the product code of K990025?

The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.