Diamedix 250-030

• FDA 510(k) K001707 decided 7 Jul 2000 Active
• FDA GUDID UDI-DI 00817273020006 listed 20 Sep 2016 Listed

1. 7 Jul 2000 Cleared FDA 510(k) K001707
2. 20 Sep 2016 Listed FDA GUDID 00817273020006

Trade name

Diamedix

Generic name

NMR spectroscopy analysis specimen preparation/calibration kit IVD

Model / reference

250-030

Primary DI / UDI-DI

00817273020006

510(k) Number

K001707 ↗

FDA product code

LGD

GMDN term

NMR spectroscopy analysis specimen preparation/calibration kit IVD

Device class

Class II

Regulation number

866.3780

GUDID distribution status

In Commercial Distribution

Category: NMR spectroscopy analysis specimen preparation/calibration kit IVD

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• TOXOPLASMA GONDII IGG by Pharmacia Diagnostics, Inc.
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• Diamedix 720-380

  Class II

  FDA 510(k) K001875 Active Cleared 21 Aug 2000 GUDID on market

• Diamedix 789-008

  Class I

  GUDID on market

• Diamedix 720-250

  Class II

  FDA 510(k) K970218 Active Cleared 8 Apr 1997 GUDID on market

• Diamedix 720-540

  Class I

  FDA 510(k) K974552 Active Cleared 28 Jan 1998 GUDID on market

See all devices from Diamedix Corp. →