KD 0.1 M Sodium Citrate Solution

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

510(k) Number

K883635 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• King Diagnostics Phosphorus Test

  Class I

  FDA 510(k) K811749 Active Cleared 10 Jul 1981

• Potassium Test

  Class II

  FDA 510(k) K811661 Active Cleared 25 Jun 1981

• Acid Phosphatase Test

  Class II

  FDA 510(k) K873726 Active Cleared 27 Jan 1988

• Calibration Kit

  Class II

  FDA 510(k) K882220 Active Cleared 2 Aug 1988

• King Diagnostics Ldh Test

  Class II

  FDA 510(k) K862306 Active Cleared 19 Aug 1986

• Albumin Test

  Class II

  FDA 510(k) K811662 Active Cleared 25 Jun 1981

See all devices from King Diagnostics, Inc. →

• What is the KD 0.1 M Sodium Citrate Solution used for?

  The KD 0.1 M Sodium Citrate Solution is a multipurpose system designed for in vitro coagulation studies. It serves as a reagent in laboratory settings, specifically for hematology applications where anticoagulation properties are required.

• How is the KD 0.1 M Sodium Citrate Solution supplied?

  The solution is supplied as a ready-to-use liquid reagent manufactured by King Diagnostics, Inc. It is designed for laboratory use and comes in a solution format appropriate for in vitro diagnostic procedures.

• What is the regulatory status of this product?

  The KD 0.1 M Sodium Citrate Solution received FDA 510(k) clearance with number K883635 on October 31, 1988. It is classified under product code JPA for hematology applications and is considered substantially equivalent to predicate devices.

• Is this solution sterile and single-use?

  The device data does not specify sterility status or whether it is single-use or reusable. As a laboratory reagent for in vitro studies, it should be handled according to standard laboratory protocols and manufacturer instructions regarding storage and disposal.