Cholestezyme-V Eiken

FDA 510(k) K821105 · Syn-Kit, Inc.

Substantially Equivalent

510(k) numberK821105

Submission

Device name
Cholestezyme-V Eiken
Applicant
Syn-Kit, Inc.
Walker, MI, US
Received
April 20, 1982
Decision date
May 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CHH – Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class I (low risk)
Regulation
21 CFR 862.1175
Specialty
Clinical Chemistry

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More from Axis-Shield Poc AS

510(k)DeviceDecision
K861098Seroiden Strepto Kit 'Eiken'GTZ · Traditional 08/12/1986SE
K861631Slide Culture U 'Eiken'JXA · Traditional 06/10/1986SE
K854819CPR Slide EikenDCN · Traditional 02/26/1986SE
K854820Ra 80 EikenDHR · Traditional 01/17/1986SE
K853276Aso Slide EikenGTQ · Traditional 08/20/1985SE
K843760Uropaper Eiken GJIL · Traditional 12/18/1984SE
K843759Uropaper Eiken HagJIL · Traditional 12/18/1984SE
K843758Uropaper Eiken GKJIL · Traditional 12/18/1984SE
K843757Uropaper Eiken AGJIL · Traditional 12/18/1984SE
K843756Uropaper Eiken 5JIL · Traditional 12/18/1984SE

Questions and answers

When was Cholestezyme-V Eiken cleared by the FDA?

Cholestezyme-V Eiken (K821105) received a 510(k) decision of Substantially Equivalent on May 5, 1982, 15 days after the submission was received.

What is the product code of K821105?

The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.