Spotcheck 302-A100-03EX

• FDA 510(k) K101392 decided 4 Feb 2011 Active
• FDA GUDID UDI-DI 00725609000281 listed 14 Oct 2016 Listed

1. 4 Feb 2011 Cleared FDA 510(k) K101392
2. 14 Oct 2016 Listed FDA GUDID 00725609000281

Trade name

Spotcheck

Generic name

Multichannel clinical chemistry analyser IVD, laboratory

Model / Ref / Catalog

302-A100-03EX

Primary DI / UDI-DI

00725609000281

510(k) Number

K101392 ↗

FDA product code

JJC

GMDN term

Multichannel clinical chemistry analyser IVD, laboratory

Device class

Class I

Regulation number

862.2150

GUDID distribution status

In Commercial Distribution

Category: Multichannel clinical chemistry analyser IVD, laboratory

Other devices filed under FDA product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use).

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• REAGENTS by Simmler & Son, Inc.
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• TECHNICON RA 1000 SYSTEM by Technicon Corp.
• REPLACEMENT REAGENTS FOR SMAC II SYSTEMS by Methodist Hospital of Memphis

• Spotcheck 80-3500-13K

  Class II

  FDA 510(k) K990957 Active Cleared 11 May 1999 GUDID on market

• Spotcheck 80-0900-01K

  Class I

  FDA 510(k) K090940 Active Cleared 14 Dec 2009 GUDID on market

• Spotcheck 307-A001-02

  Class I

  FDA 510(k) K101392 Active Cleared 4 Feb 2011 GUDID on market

• Spotcheck 303-A980-00B

  Class I

  FDA 510(k) K883020 Active Cleared 2 Sep 1988 GUDID on market

See all devices from Astoria-Pacific, Inc. →