Spotcheck 303-A980-00A

• FDA 510(k) K883020 decided 2 Sep 1988 Active
• FDA GUDID UDI-DI 00725609000496 listed 14 Oct 2016 Listed

1. 2 Sep 1988 Cleared FDA 510(k) K883020
2. 14 Oct 2016 Listed FDA GUDID 00725609000496

Trade name

Spotcheck

Generic name

Multichannel clinical chemistry analyser IVD, laboratory

Model / Ref / Catalog

303-A980-00A

Primary DI / UDI-DI

00725609000496

510(k) Number

K883020 ↗

FDA product code

JJF

GMDN term

Multichannel clinical chemistry analyser IVD, laboratory

Device class

Class I

Regulation number

862.2170

GUDID distribution status

In Commercial Distribution

Category: Multichannel clinical chemistry analyser IVD, laboratory

Other devices filed under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use).

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• RAPID CHEM ANALYZER II by Macomb Chemical Co.
• HYBRITECH IMMUNOCHEMISTRY ANALYZER by Hybritech, Inc.
• PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER by Kone Instruments, Inc.
• SHABAN 9865 IL#78637 JUNCTION BLOC by Shaban Mfg. Co.
• LIGHTCYCLER INSTRUMENT VERSION 1.2 by Roche Diagnostics Corp.
• WINMAX SOFTWARE SYSTEMS by Diagnostic Products Corp.
• MODIFIED PK300 AUTOMATIC EIA ANALYZER by Olympus Corp.
• WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS by Waters Chromatography Division
• COBAS MIRA by Roche Diagnostic Systems, Inc.

• 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. →