Colorimetric Ldh Reagent Set

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K820768 ↗

FDA Product Code

CFH

Device Class

Class II

Regulation

21 CFR Part 862.1440

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Optimized UV-Gpt Reagent Set

  Class I

  FDA 510(k) K822494 Active Cleared 21 Sep 1982

• UV Uric Acid Determination

  Class I

  FDA 510(k) K813244 Active Cleared 8 Dec 1981

• Cholesterol Determination

  Class I

  FDA 510(k) K811760 Active Cleared 10 Jul 1981

• Optimized UV-Got Reagent Set

  Class II

  FDA 510(k) K822493 Active Cleared 21 Sep 1982

• Optimized UV-Ldh Reagent Set

  Class II

  FDA 510(k) K822492 Active Cleared 17 Sep 1982

• Colorimetric Uric Acid Reagent Set

  Class I

  FDA 510(k) K820632 Active Cleared 25 Mar 1982

See all devices from Biorent Diagnostic, Inc. →

• What is the Colorimetric LDH Reagent Set used for?

  The Colorimetric LDH Reagent Set is used for the detection of lactate dehydrogenase in clinical chemistry settings, utilizing a tetrazolium int dye-diaphorase reaction.

• Is the Colorimetric LDH Reagent Set supplied with any specific regulatory codes?

  Yes, the device is supplied with a product code of CFH and a regulation number of 862.1440, indicating its classification and intended use.

• What type of clearance does the Colorimetric LDH Reagent Set have?

  The Colorimetric LDH Reagent Set has been authorized with an FDA 510K clearance, indicating it is substantially equivalent to a predicate device.

• What is the device class of the Colorimetric LDH Reagent Set?

  The Colorimetric LDH Reagent Set has a device class of 2, as designated by the FDA.