ACE Normal Control SC-131

• FDA 510(k) K940272 decided 20 Apr 1994 Active
• FDA GUDID UDI-DI 00817869020281 listed 31 Jan 2019 Listed

1. 20 Apr 1994 Cleared FDA 510(k) K940272
2. 31 Jan 2019 Listed FDA GUDID 00817869020281

Trade name

ACE Normal Control

Generic name

Angiotensin converting enzyme (ACE) IVD, control

Model / Ref / Catalog

SC-131

Primary DI / UDI-DI

00817869020281

510(k) Number

K940272 ↗

FDA product code

JJX

GMDN term

Angiotensin converting enzyme (ACE) IVD, control

Device class

Class I

Regulation number

862.1660

GUDID distribution status

In Commercial Distribution

Category: Angiotensin converting enzyme (ACE) IVD, control

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See all devices from Analytical Control Systems →