Cholesterol Standard #65077

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

510(k) Number

K822474 ↗

FDA Product Code

JIS

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Ultrachem Uric Acid Aidh, #65047

  Class I

  FDA 510(k) K821465 Active Cleared 2 Jun 1982

• Phosphorus Test (Phos) Item Number 65416

  Class I

  FDA 510(k) K945322 Active Cleared 7 Dec 1994

• Immunohematological Saline #97139

  Class I

  FDA 510(k) K831200 Active Cleared 9 May 1983

• Midas 1000 Wright Stain #66010

  Class I

  FDA 510(k) K822980 Active Cleared 27 Oct 1982

• Ultrachem E-Glu, #64976 & 65040

  Class II

  FDA 510(k) K821461 Active Cleared 2 Jun 1982

• Unitized Hematology Set 65132/93

  Class I

  FDA 510(k) K840477 Active Cleared 5 Mar 1984

See all devices from Emd Chemicals, Inc. →

• What is the Cholesterol Standard #65077 used for in a clinical setting?

  The Cholesterol Standard #65077 is a primary calibrator designed specifically for the quantitative measurement of cholesterol in clinical chemistry laboratories. It serves as a reference material to ensure the accuracy and consistency of analytical instruments, helping maintain precise calibration for reliable test results.

• Is the Cholesterol Standard #65077 intended for single-use or reusable applications?

  The Cholesterol Standard #65077 is explicitly labeled as a single-use reagent. This designation ensures optimal performance and sterility control for each calibration procedure, preventing cross-contamination or degradation over repeated use.

• What type of regulatory clearance does the Cholesterol Standard #65077 hold, and how was it approved?

  The Cholesterol Standard #65077 was granted FDA 510(k) clearance under the Traditional pathway, with a clearance number of K822474. It is classified as a Class II device under FDA regulations (21 CFR 862.1150) and was determined to be substantially equivalent to a predicate device.

• Is the Cholesterol Standard #65077 sterile, and if not, what are the implications for laboratory use?

  The Cholesterol Standard #65077 is explicitly described as non-sterile. Since it is used for calibration rather than direct patient testing, sterility is not a primary concern. However, laboratories should follow standard aseptic techniques when handling the reagent to prevent contamination of instruments or samples.

• Are there different sizes or models of the Cholesterol Standard #65077, or is it supplied in a single formulation?

  The provided data does not specify multiple sizes or models for the Cholesterol Standard #65077. It is described as a single formulation intended for quantitative cholesterol measurement, implying a standardized product without variations in concentration or packaging.